Quality Engineer I

Join Penumbrainc as a Quality Engineer I and play a vital role in ensuring the excellence of our products. In this entry-level position, you will be responsible for performing quality assurance tasks, collaborating with cross-functional teams, and contributing to the development of innovative solutions. If you are passionate about quality and eager to start …

General OverviewAs a Quality Engineer I at Penumbra, you will be instrumental in ensuring the excellence of our groundbreaking medical devices designed to combat some of the most challenging health conditions globally. Unlike traditional quality engineering roles, our environment presents you with complex technical challenges. Your contributions will significantly influence the safety and well-being of patients worldwide who rely on our innovations. You will harness your creative problem-solving skills throughout all phases, from initial concept through commercialization and ongoing enhancements.Your Responsibilities• Contribute valuable insights to the design control process and assist in the development and launch of new products.• Utilize your expertise in Penumbra’s Quality Management System to support manufacturing operations, supplier quality, and new product development.• Identify and lead initiatives for process optimization, yield enhancement, and cycle time reduction.• Investigate and resolve root causes of in-process quality assurance issues.• Collaborate on production lines that manufacture high-performance products.• Comply with the Company’s Quality Management System (QMS), along with domestic and international quality regulations, standards, and procedures.• Ensure adherence to QMS and regulations by department members.• Engage in additional activities that require familiarity with principles and techniques relevant to specific project areas.What You Bring• A minimum of 1 year of experience in a manufacturing or laboratory setting is strongly preferred.• Demonstrated ability to excel in a dynamic, fast-paced environment where ambiguity is embraced.• A Bachelor’s or Master’s degree in engineering or a scientific discipline is required.• Exceptional written and verbal communication skills are essential.• A strong enthusiasm for collaboration in a feedback-rich team culture is preferred.Working Environment• Office, laboratory, and cleanroom settings.• Possible exposure to blood-borne pathogens.• Physical requirements include lifting and moving items up to 25 pounds.• Ability to navigate between buildings and floors is necessary.• Must remain stationary and utilize computer or standard office equipment for extended periods.• Must be capable of reading, drafting emails, and creating documents and spreadsheets.• Ability to move within the office and access supplies as necessary.• Must effectively communicate and exchange accurate information with colleagues at all levels daily.Location and Compensation• Alameda, CA• Salary range: $80,000 to $105,000

Join our dynamic team at Penumbra Inc., where we are committed to advancing healthcare through innovative solutions. As a Quality Assurance Engineering Specialist I, you will play a crucial role in ensuring the highest quality standards are met throughout our product development lifecycle. Your attention to detail and analytical skills will contribute to our mission of improving patient outcomes.

General OverviewAs a Supplier Quality Engineer II at Penumbra, you will be instrumental in ensuring that our supply chain consistently provides components and materials that adhere to the highest quality and compliance standards. Collaborating closely with cross-functional teams in Operations, Compliance, and R&D, you will lead supplier qualifications, manage changes, implement corrective actions, and monitor performance metrics. Your role will include resolving supplier-related issues, driving enhancements, and ensuring compliance with Penumbra’s Quality Management System (QMS) and applicable regulatory standards.This position presents an exceptional chance to contribute significantly to a high-impact quality organization by spearheading supplier quality initiatives. You will join a collaborative and expanding team that prioritizes technical development and career advancement.Key Responsibilities• Manage daily supplier quality challenges and drive their resolution, coordinating efforts with Engineering and Operations while maintaining effective communication with suppliers.• Provide technical and quality support for Incoming Quality Control (IQC) and lead improvement initiatives for supplier and IQC processes.• Ensure alignment of supplier inspection and testing methods with Penumbra’s internal standards.• Investigate supplier-related failures (e.g., IQC nonconformances) and support corrective and preventive action processes.• Own and manage Supplier Corrective Actions (SCARs) by facilitating root cause analysis and implementing corrective actions in collaboration with suppliers.• Oversee Second Source Qualifications (SSQs) and Supplier Change (SC) activities, including conducting technical risk assessments and documentation management.• Initiate and manage Supplier Notifications (SNs) and ensure that supplier quality actions are tracked to completion.• Participate in monitoring and trending supplier performance metrics to identify opportunities for improvement.• Coordinate the qualification of new suppliers and assist in the maintenance of the Approved Supplier List (ASL).• Ensure compliance with Penumbra’s QMS and relevant domestic and international regulations (e.g., QSR, ISO 13485).• Collaborate across departments to strengthen supplier relationships and drive continuous improvements in product quality and reliability.• Represent Supplier Quality Engineering in project teams, taking ownership of supplier quality efforts to achieve project goals.• Design experiments and tests, applying statistical methods to analyze and interpret engineering test data.Qualifications• Bachelor’s degree in engineering, science, or a related discipline.• Minimum of 3 years of experience in engineering, preferably within the medical device sector, or an equivalent combination of education and experience demonstrating performance excellence.

Join GeneFab as a Quality Control Analyst I/II, where you will play a crucial role in upholding the quality of our innovative cell manufacturing processes. In this pivotal position, you will be responsible for conducting laboratory tests on incoming raw materials, in-process samples, and final product samples prior to distribution. Your analytical skills will ensure that product specifications are consistently met, and you will be involved in peer reviews of analytical findings. Additionally, you will evaluate current Good Manufacturing Practice (GMP) documentation, including Standard Operating Procedures (SOPs), testing methods, and protocols to ensure compliance and efficiency.

Role Overview genefab seeks a Director of Quality Assurance to lead quality initiatives and embed compliance throughout daily operations. This on-site role in Alameda, CA, shapes the company's approach to quality, operational excellence, and ongoing improvement. The Director will ensure that quality standards align with long-term strategy and are consistently applied across teams and projects. Key Responsibilities Provide strategic leadership for all Quality Assurance functions Oversee integration of quality standards and compliance measures into daily operations Drive harmonization of quality processes, including risk management and GMP systems Ensure compliance with global regulatory requirements Build collaborative partnerships with cross-functional stakeholders to support business objectives What We’re Looking For Extensive experience in Quality Assurance Operations Demonstrated leadership skills and a proactive approach to continuous improvement Background in both clinical and commercial stages Proven track record as a Director of Quality Assurance Operations in CDMO/CMO settings Experience with cell therapy and viral vector programs Location This role is based on-site in Alameda, CA.

Join Genefab's Quality Control Analytical group as a Senior Analyst II, where your expertise will be pivotal in supporting our Good Manufacturing Practices (GMP) Quality Control testing. You will be responsible for method transfer, qualification, troubleshooting, and conducting thorough investigations. This role demands a keen analytical mindset and a commitment to maintaining the highest quality standards.

THE COMPANYSaildrone is a pioneering maritime defense organization and the foremost authority in autonomous unmanned surface vehicles (USVs). With unparalleled experience traversing ocean miles and real-world operations, Saildrone actively supports national security and force projection globally, 24/7/365.Our manufacturing and R&D headquarters are situated in Alameda, CA, complemented by business development and sales operations in Washington, DC, and deployment hubs across Europe and the Middle East. By integrating proven autonomous operations, edge computing, advanced sensing, renewable energy, and cutting-edge unmanned surface technology, Saildrone is redefining the operational capabilities of future naval forces. Come be a part of a dynamic, mission-driven team at the forefront of maritime security and autonomous innovation.THE POSITIONWe are looking for a Senior Operations Quality Manager to enhance our Operations Team. Reporting directly to the Chief Operating Officer, you will spearhead the daily execution and evolution of our Quality Management System, ensuring that every vehicle delivered meets the highest standards of reliability, traceability, and performance. As production scales and product complexity increases, you will guarantee that our quality systems advance in tandem with the business—from supplier qualifications through manufacturing, deployment, and fleet operations. We seek a hands-on technical leader adept at creating clarity from ambiguity, driving disciplined follow-through, and possessing a proven history of successful execution in fast-paced hardware environments.THE TEAMThe Operations Team oversees the manufacturing, deployment, and maintenance of Saildrone’s autonomous surface vehicles. We develop and uphold the operational infrastructure necessary to ensure global maritime domain awareness within a national security and defense framework. Quality is central to this mission—connecting manufacturing and field service to swiftly identify issues, thoroughly resolve root causes, and close feedback loops efficiently. This role collaborates across Engineering, Supply Chain, Production, and Technical Operations to maintain rigor as we scale.THE RESPONSIBILITIESMature and expand the Quality Management System (QMS) to achieve ISO9001 and/or AS9100D compliance, overseeing internal/external audits, documentation controls, and traceability systems to meet stringent certification criteria.Establish and manage company-wide quality KPIs (e.g., First Pass Yield, defect rate, cost of quality) and reporting dashboards to provide...

Position OverviewAs a Research and Development Engineer I at Penumbra, Inc., you will play a pivotal role in the engineering, design, and development of innovative products and enhancements to existing offerings. Your responsibilities will include conducting rigorous testing, implementing engineering modifications, and meticulously documenting changes. You will leverage both theoretical knowledge and practical applications using scientific methods and design experiments to deliver effective solutions.Key Responsibilities• Collaborate on the design, development, and testing of Penumbra, Inc. products.*• Develop comprehensive engineering test protocols.*• Execute and report on engineering tests.*• Design specialized fixtures and tooling to streamline prototype assembly and material testing.• Assess prototypes against established standards and specifications; troubleshoot issues to determine root causes and corrective actions.• Analyze and communicate test results effectively.*• Address practical challenges encountered during development.*• Document findings and propose recommendations.*• Present findings to project managers.*• Comply with the Company's Quality Management System (QMS) as well as applicable domestic and global quality regulations, standards, and procedures.*• Understand and adhere to relevant security, privacy, and compliance regulations applicable to the Company.*• Ensure compliance with QMS and other relevant regulations among team members.*• Perform additional duties as assigned.*Indicates essential functions of the role.

Role Overview Penumbra Inc. is seeking a Quality Assurance Manager for Training Services to join the team in Alameda, CA. This position focuses on maintaining the integrity of the Quality System and processes, with a strong emphasis on overseeing the Quality Training System and related services. The manager will lead projects to ensure compliance with internal procedures and regulatory standards. Key Responsibilities Recruit, manage, and develop staff by setting clear objectives and providing ongoing feedback through performance evaluations and development plans. Align group activities with corporate goals and initiatives. Coordinate global training efforts to ensure regulatory compliance and proper training for team members. Analyze situations thoroughly, considering multiple factors to resolve issues and drive improvements. Review procedures and work instructions, recommending and implementing changes to policies as needed. Act as a subject matter expert for Training, participating in cGMP compliance inspections by the FDA and other regulatory bodies. Responsibilities include gathering quality documents, records, and trend data, and defending Quality System processes during inspections. Manage and drive Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs) related to the Training System. Communicate process changes and provide training to internal customers. Deliver Quality and MasterControl Orientation training sessions. Address and resolve quality system training issues and inquiries from across the organization. Recommend, implement, and document solutions for systemic training-related challenges. Analyze regulatory, business, and customer requirements, along with current industry best practices, to propose and implement necessary adjustments to the Training System. Design, develop, and implement the Training System curriculum in partnership with functional leadership. Promote a safe, positive, and inclusive workplace culture.

Role Overview The Manufacturing Engineer I – Electronics Development at Penumbra Inc. plays a hands-on role in advancing manufacturing technology and supporting the launch and improvement of new products. Based in Alameda, CA, this position works closely with multiple engineering teams to troubleshoot production challenges and implement solutions that improve manufacturing processes and quality systems. The role offers the chance to build technical skills while contributing to projects that impact Penumbra’s global operations. What You Will Do Identify and resolve production issues using creative problem-solving methods. Conduct thorough root cause analyses and recommend effective solutions. Collaborate with various departments to communicate issues and share solutions. Maintain a detail-oriented approach to troubleshooting and documentation. Support day-to-day production activities, including creating and updating product and process documentation. Monitor equipment and process performance, and initiate improvement activities to boost yield, efficiency, and throughput. Design production fixtures, source tools and equipment, and implement new fixturing on the line, including equipment qualification. Test processes, equipment, raw materials, and finished products; conduct process validations; write testing protocols; and compile reports with findings and recommendations. Plan, schedule, and coordinate detailed phases of engineering work as part of a team or independently. Develop specifications for products, processes, or equipment. Apply statistical methods and engineering knowledge to develop, characterize, and optimize manufacturing processes. Work with suppliers and external partners to develop and implement process improvement plans. Participate in project planning and scheduling activities. Train assemblers, quality control staff, and technicians on processes, equipment, and documentation as needed. Follow Penumbra’s Quality Management System (QMS) and comply with domestic and international quality standards and regulations. Understand and adhere to relevant security, privacy, and compliance regulations applicable to the company.

OverviewThe Manufacturing Engineering team is pivotal in introducing advanced manufacturing technologies and sustainable practices that facilitate the launch of innovative products and enhance production efficiency. This role offers a unique opportunity to cultivate professional skills while contributing to projects of significant global impact, essential for our organization's success. You will collaborate closely with production and cross-departmental engineering teams to address challenges that arise on the production floor and throughout the organization.Key Responsibilities•Identify and solve production challenges by implementing creative solutions. *•Conduct thorough root cause analyses and propose validated solutions. *•Effectively communicate and clarify issues and solutions across various departments. *•Maintain a meticulous approach to problem-solving. *•Support production by creating and updating product and process documentation; track equipment performance and implement improvements to enhance yield, efficiency, and throughput. *•Design fixtures, procure off-the-shelf tooling and equipment, and introduce new fixturing on the production line while conducting equipment qualifications. *•Test processes, equipment, raw materials, and products; perform process validations, author testing protocols, and document findings with recommendations based on results. *•Plan, schedule, and oversee detailed phases of engineering projects. *•Develop specifications for products, processes, or equipment. *•Utilize statistical techniques and engineering expertise to develop, characterize, and optimize processes. *•Collaborate with suppliers and external resources to enhance process improvement initiatives. *•Engage in project planning and scheduling. *•Provide training to assemblers, quality control personnel, and technicians on processes, equipment, and documentation. *•Comply with the Company’s Quality Management System (QMS) and relevant quality regulations and standards. *•Understand and adhere to applicable security, privacy, and compliance principles. *

About UsAt Sila, we are pioneering the future of battery materials with a commitment to driving the global shift toward clean energy. Our innovative team is dedicated to developing superior lithium-ion batteries that enhance energy density while minimizing size and weight. This transformation leads to more compact and powerful batteries, aiding advancements in consumer electronics and facilitating the widespread adoption of electric vehicles, ultimately reducing our reliance on fossil fuels. Join us in tackling one of the most significant challenges of our era and redefine possibilities with us.Who You AreAs the Senior Project Manager, you will take charge of the quality management systems, procedures, and documentation for large-scale capital projects and smaller improvement initiatives, ensuring that all work meets the highest specifications, codes, regulations, and safety standards. Your proactive approach will be crucial in developing QA programs and QC plans, conducting site audits, managing contractor compliance, and mitigating risks effectively.This role is primarily located in Alameda, California, requiring regular onsite presence at construction sites, offices, and client locations to oversee auditing, operations, inspections, and reporting.

OverviewThe Equipment Technician I plays a crucial role in ensuring the optimal setup, maintenance, and documentation of Penumbra’s manufacturing and testing equipment, adhering to our established Quality System standards. This position is vital for maintaining operational excellence within our innovative environment.Work Schedule: Monday to Friday, 3 PM to 11:30 PM.Key Responsibilities• Conduct and document maintenance activities, including preventive maintenance, on-demand repairs, and non-standard fixes, in compliance with quality system protocols. • Collaborate with fellow technicians to assist in on-demand maintenance and troubleshooting tasks as necessary. • Execute on-demand maintenance and troubleshoot equipment issues effectively. • Oversee equipment installation and validation processes, including IQ/OQ (Installation Qualification/Operational Qualification), to ensure equipment functions correctly. • Manage spare parts inventory through our system, ensuring accurate inventory levels are maintained. • Support senior technicians in resolving equipment-related manufacturing challenges. • Assemble equipment and fixtures per documented specifications. • Participate in manufacturing line relocations and equipment moves as required. • Uphold the company’s Quality Management System (QMS) along with domestic and international quality regulations. • Ensure compliance with relevant security, privacy, and regulatory principles. • Mentor team members on adhering to QMS, regulations, and procedures. • Perform other duties as assigned.*Essential functions of the role are marked.

General OverviewJoin the dynamic Manufacturing Engineering team at Penumbra, where you'll tackle intricate challenges and devise groundbreaking solutions. Your role will focus on providing advanced manufacturing technology, optimizing production processes, and facilitating the successful commercialization of new products. By collaborating across various engineering divisions, as well as with Production, Quality Control, and Quality Assurance teams, you will address and resolve production floor issues and implement creative engineering enhancements to both production lines and quality systems.Your Responsibilities• Address complex engineering challenges with innovative solutions.• Perform thorough root cause analysis and propose effective solutions.• Facilitate communication of problems and solutions across departments.• Collaborate with suppliers to ensure effective communication and timely updates.• Manage Non-Conformance Reports (NCRs), deviations, engineering change orders, and supplier documentation, leveraging a Quality Management System for continuous improvement.• Engage in troubleshooting electromechanical products using failure analysis techniques and implement actionable solutions.• Lead supplier-level project implementations, ensuring adherence to timelines and milestones.• Approach problems with a meticulous, detail-oriented mindset.• Provide independent recommendations for project strategies and execution.• Support production requirements effectively.• Create and uphold comprehensive product and process documentation.• Monitor and enhance process and equipment performance, focusing on yield optimization.• Design fixtures, procure tools and equipment, and integrate new fixtures into production.• Test and validate processes, equipment, raw materials, and end products.• Author test protocols and reports, drawing conclusions and recommendations from test outcomes.• Plan, schedule, and coordinate engineering phases within projects.• Develop specifications for products, processes, or equipment.• Utilize statistical techniques and engineering expertise to develop and refine processes.• Collaborate with suppliers and external resources for effective process improvement initiatives.

Join Penumbra as a Quality Engineer and play a pivotal role in ensuring the quality and safety of our revolutionary medical devices designed to tackle some of the most challenging health conditions globally. You will engage with complex, technical challenges that require innovative solutions, influencing every phase from initial concept through commercialization, and driving continual enhancements. Your passion for creative problem-solving will be vital as you contribute to the well-being of patients worldwide.

OverviewJoin our innovative team at Penumbra, Inc., where you will play a pivotal role in ensuring the production of high-quality, life-saving medical devices. As a Senior Quality Engineer, you will independently manage significant projects, collaborating closely with Commercial Operations to uphold the highest standards in the manufacturing of Class II/III interventional medical devices. This position challenges you to analyze complex problems, leveraging your expertise to make informed decisions regarding quality actions and to communicate and implement quality objectives effectively.Key Responsibilities• Collaborate with Commercial Operations and Manufacturing teams on activities such as Incoming/In-process/Final Inspections, Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), Engineering Change Orders, Control Chart Investigations, Deviation Authorizations, and equipment maintenance tasks.• Support specific product lines by performing failure analyses and investigating defects as necessary.• Drive Continuous Improvement initiatives and collaborate on their execution.• Engage in supplier-related activities including Second Source Qualifications, Supplier Changes, and Supplier Corrective Action Requests (SCARs).• Work closely with engineering departments and suppliers to address quality-related concerns.• Lead or contribute to the development of manufacturing documentation.• Design, enhance, and support test methodologies, testing equipment, and test method validations (TMVs).• Suggest updates to specifications, acceptance criteria, and manufacturing documents to enhance product quality and operational efficiency.• Mentor junior Quality Engineers, providing guidance in departmental functions.• Fulfill responsibilities outlined by the Quality Management System (QMS) and perform additional duties as assigned.• Ensure departmental compliance with QMS, regulations, standards, and procedures.• Execute other work-related tasks as directed.QualificationsMinimum Education and Experience:• Associate's or Bachelor's degree in Engineering, Life Sciences, or a related field with a minimum of 3 years of relevant experience in quality engineering, preferably within the medical device industry, or an equivalent combination of education and experience.Additional Qualifications:• Strong knowledge of QSR, ISO, and applicable regulations and standards is essential.• Exceptional verbal, written, and interpersonal communication skills are required.• Demonstrated leadership abilities are preferred.• Proficiency in MS Office Suite (Word, Excel, PowerPoint) is required.Working Environment• The role is situated in general office, laboratory, and cleanroom settings, promoting a collaborative and innovative atmosphere.

OverviewJoin our dynamic team at Penumbra, Inc. as a Manager of Quality Engineering, where you will spearhead a talented group of Quality Engineers dedicated to enhancing the manufacturing operations and production lines for our innovative range of medical devices. Your leadership will be pivotal in ensuring the highest standards of manufacturing quality performance, developing effective inspection strategies, optimizing yield, and maintaining robust process controls throughout the product lifecycle, from initial commercial ramp-up to product maturity and site transfer.As a key member of our Technical Operations team, you will collaborate closely with Manufacturing Engineering, Production, and Industrial Engineering to embed quality into the manufacturing processes from the outset. With a commitment to quality excellence, you will implement effective process controls, inspection strategies, and data-driven monitoring to mitigate risks. Your efforts will directly contribute to improved product yield, enhanced productivity, and operational stability by preventing defects, identifying issues at their inception, and ensuring a consistent, compliant manufacturing performance.Key Responsibilities• Provide leadership for Quality Engineering across assigned product portfolios and production lines.• Act as the primary quality liaison for Production, Manufacturing Engineering, and Industrial Engineering.• Oversee manufacturing quality performance metrics, including yield, scrap, productivity, and throughput-related quality losses.• Develop and refine comprehensive inspection strategies, including in-process checks, final inspections, destructive testing, sampling plans, and acceptance/rejection criteria.• Initiate and lead continuous improvements in inspection systems, testing methodologies, process monitoring, and digital quality tools.• Employ Lean and Six Sigma principles to enhance yield, minimize waste, and improve process capability.• Manage quality system activities within Operations, including Non-Conformance Reports (NCRs), Material Review Board (MRB) activities, Corrective and Preventive Actions (CAPAs), control chart investigations, and effectiveness verification.• Advocate for process-based risk management, including performing process Failure Mode and Effects Analyses (pFMEAs) and defining Critical to Quality (CTQ) metrics.• Review and endorse equipment-related quality tasks, such as equipment qualifications (IQ/OQ), equipment change orders (ECOs), non-standard maintenance activities, and equipment software validation, in collaboration with Manufacturing Engineering.• Recruit, develop, and manage a team of Quality Engineers, overseeing workload and FTE planning to align with production priorities.*Essential functions of the role.

General OverviewAs a Senior Quality Engineer with Penumbra Inc, you will play a pivotal role in enhancing our manufacturing operations and production lines for a diverse array of medical devices. Leveraging your strong analytical and problem-solving capabilities, you will maintain process control, bolster inspection and monitoring frameworks, and drive yield and quality enhancements from the early stages of commercial ramp-up through to established production. This position demands a high level of independent judgment, extensive technical expertise, and the adaptability to apply standard engineering and quality practices to intricate manufacturing challenges. You will autonomously plan and execute your work, innovate solutions to complex issues, and actively contribute to the development, implementation, and ongoing enhancement of quality standards within Operations. Collaborating closely with Manufacturing Engineering, Production, and Industrial Engineering, you will ensure that quality is integrated at every stage of the manufacturing process.Key Responsibilities• Deliver Quality Engineering support for designated products and production lines• Serve as a crucial quality partner for Production, Manufacturing Engineering, and Industrial Engineering• Lead in-depth root cause investigations utilizing structured problem-solving methodologies (5 Whys, Fishbone diagrams, DOE, regression analysis)• Monitor manufacturing quality performance metrics, including yield, scrap rates, and process capability• Advocate for and enhance inspection strategies encompassing in-process and final inspections, destructive testing, sampling plans, and acceptance criteria• Spearhead continuous improvement initiatives for inspection systems, testing methodologies, process monitoring, and digital quality tools• Employ Lean and Six Sigma principles to minimize waste and enhance process capability• Implement quality system activities within Operations, including Non-Conformance Reports (NCRs), Material Review Board (MRB) actions, Corrective and Preventive Actions (CAPAs), control chart investigations, and effectiveness verifications• Conduct and maintain process Failure Mode Effects Analyses (pFMEAs), ensuring that risks are effectively mitigated through appropriate controls and monitoring• Assist in the early commercial ramp-up, material or process modifications, and site transitions.Required Qualifications• Bachelor’s degree in Engineering (preferred disciplines: Biomedical, Mechanical, Materials, Chemical or related field)• 5+ years of experience in Quality Engineering or Manufacturing Engineering within the medical device industry• Proven experience in supporting manufacturing operations, process development, or New Product Introduction (NPI)• Familiarity with FDA Quality System Regulations (QSR) and ISO 13485 within a manufacturing context• Exceptional data analysis, problem-solving, and decision-making skills.Preferred Qualifications• Certified Quality Engineer (CQE) or equivalent training• Experience in supporting high-volume manufacturing and early commercial phases.

General SummaryThe Quality Engineer II plays a crucial role in developing and executing robust quality system elements to uphold the excellence of both new and existing product lines. This position ensures compliance with pertinent regulations and standards while addressing moderate-scope problems that require in-depth analysis of identifiable factors. The engineer will exercise sound judgment to determine optimal actions and effectively communicate and implement quality objectives across the organization.Specific Duties and Responsibilities• Collaborate in the development and qualification processes for both new and existing products.• Develop comprehensive testing and inspection methodologies along with associated documentation.• Engage actively with Quality Objective teams.• Design and implement Quality Control (QC) process sampling systems, procedures, and statistical techniques.• Specify or design inspection and testing mechanisms and equipment tailored for product requirements.• Conduct failure analyses and defect investigations to enhance product quality.• Analyze production limitations and standards to recommend improvements.• Suggest revisions to specifications to align with quality standards.• Interface effectively with engineering departments, customers, and suppliers on quality-related issues.• Assist in the creation of standard operating procedures (SOPs).• Facilitate and conduct internal audits to ensure compliance.• Adhere to the Company's Quality Management System (QMS) and global quality regulations and standards.• Understand and comply with relevant security, privacy, and compliance principles.• Ensure adherence to QMS, regulations, standards, and procedures within the department.• Undertake additional work-related duties as assigned.*Indicates essential functions of the role.Location and Salary:• Location: Alameda, CA• Salary: $95,000 to $127,000• Compensation is subject to variation based on performance, skill level, competencies, work location, and shift.Position QualificationsMinimum education and experience: • Associate’s or Bachelor's degree in Engineering, Life Sciences, or a related field, with a minimum of 2 years of relevant experience in quality engineering, preferably within the medical devices or regulated industry, or an equivalent combination of education and experience.Additional Qualifications:• Strong familiarity with Quality System Regulations (QSR), ISO standards, and other applicable regulations and laws related to quality engineering.