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Experience Level
Entry Level
Qualifications
Ideal candidates will possess a Bachelor’s Degree in a relevant field, alongside a keen eye for detail and a commitment to quality assurance. Previous experience in a laboratory environment, preferably within a manufacturing setting, is highly desirable. Strong analytical skills, familiarity with GMP standards, and the ability to work collaboratively in a team are essential for success in this role.
About the job
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.
About GeneFab
GeneFab is a leader in cell manufacturing, dedicated to advancing the frontiers of biotechnology. Our commitment to quality and innovation sets us apart in the industry, and we are looking for passionate individuals to join our team and contribute to our mission of excellence.
Full-time|$152.3K/yr - $192.1K/yr|On-site|Alameda, California, United States
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 i…
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.
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.
Full-time|$149.4K/yr - $198K/yr|On-site|Alameda, California, United States
THE COMPANYSaildrone is a pioneering maritime defense organization, recognized as the global leader in autonomous unmanned surface vehicles (USVs). With unmatched operational experience and extensive ocean mileage, Saildrone actively deploys combat-ready systems that support national security and force projection globally, 24/7/365.Our manufacturing and R&D headquarters are based in Alameda, CA, with business development and sales operations in Washington, DC, and deployment hubs in Europe and the Middle East. By integrating proven autonomous operations, edge computing, advanced sensing technologies, and renewable energy sources, Saildrone is revolutionizing the operational capabilities of the Navy for the future. Join our dynamic, mission-driven team at the forefront of maritime security and autonomous technologies.THE POSITIONWe are in search of a Senior Engineering Manager for Technical Field Operations to become a part of our Fleet Management team within the Operations division. This role reports directly to the Vice President of Fleet Operations and is pivotal in shaping the reliability architecture and leading the technical defense of Saildrone’s autonomous fleet. The ideal candidate will excel in clarifying ambiguity, managing high-stakes incidents, and transforming complex real-world telemetry into robust, scalable engineering solutions.THE TEAMThe Fleet Management team is tasked with ensuring the performance, reliability, and operational success of Saildrone’s autonomous vehicles during live deployments. Our focus is on maintaining constant fleet oversight and converting field data into actionable technical strategies to provide resilient solutions for global maritime domain awareness, within a national security and defense framework. This team effectively bridges the gap between high-level engineering strategies and tangible hardware performance in challenging maritime environments.THE RESPONSIBILITIESLead technical watchfloor operations and fleet oversight to ensure 24/7 mission success, managing on-call rotations and executing high-priority incident responses across global deployments.Oversee fleet reliability and uptime metrics (SLIs, SLOs, and Error Budgets), delving beyond surface-level issues to identify and rectify systemic failures within embedded systems and networking.Collaborate closely with Product Engineering and Mission Management to prioritize initiatives, advocating for a balance between technical debt and operational efficiency.
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.
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.
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 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 your career in engineering, we want to hear from you!
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
Full-time|$120K/yr - $150K/yr|On-site|Alameda, California, United States
Join our dynamic team at anthro as a People Operations and Talent Manager, where you will play a pivotal role in shaping our employee experience and enhancing our human resources systems as we continue to grow. In this multifaceted role, you will collaborate across various departments including People Operations, compliance, systems, and recruitment to establish robust processes, ensure compliance, and provide an exceptional experience for both candidates and employees. You will become a trusted advisor to managers and a key resource for the team, helping to foster a culture and operational framework that aligns with anthro's mission and growth objectives.People Operations & Compliance (40–50%)Collaborate with the Finance team to guarantee timely and accurate payroll processing each cycle.Regularly update and maintain our employee handbook, policies, and comprehensive employee lifecycle processes.Take ownership of onboarding and offboarding processes, ensuring a seamless transition for employees.Conduct regular audits to ensure accuracy within our HRIS and ATS.Manage compliance with federal, state, and local regulations, maintaining precise documentation and employee files.Act as the primary contact for employee inquiries, escalating issues as necessary.Assist in organizing and coordinating company events, offsites, and culture-building initiatives.People Systems (20–30%)Develop tools, templates, and data for performance evaluations, compensation cycles, and other HR programs, optimizing processes for automation where applicable.Recruiting & Hiring (30–40%)Oversee and coordinate recruitment efforts across various roles and teams.Collaborate with hiring managers to establish role requirements, scorecards, and interview strategies.Serve as the proactive point of contact, ensuring timely and organized communication throughout the hiring process for team members and candidates.Post job openings, promote positions, and liaise with recruiting agencies.Manage candidate sourcing, scheduling, phone screenings, and overall candidate experience.Maintain consistency, equity, and efficiency in recruitment processes.
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.
E11 Bio is a pioneering nonprofit organization dedicated to a transformative neuroscience initiative: the development of an innovative technology platform aimed at scalable mammalian brain mapping. As a Focused Research Organization backed by Convergent Research, our mission is not just to advance neuroscience and the next generation of AI, but to make a meaningful difference for millions affected by neurological disorders. Join our collaborative, interdisciplinary team of scientists and engineers at the cutting edge of connectomics. Explore our technology roadmap to learn more.We are on the lookout for a skilled Director of Operations to lead and mentor a dedicated operations team, providing strategic operational leadership across all organizational systems.This full-time, exempt leadership position is crucial in ensuring that our scientific pursuits are effectively supported by robust operational practices. You will oversee the operations team while creating scalable systems that facilitate E11’s growth trajectory. Collaborating closely with scientific leadership, you will play a pivotal role in guiding planning, managing risks, and ensuring that our ambitious technical objectives are complemented by operational excellence.This position is based on-site in Alameda, CA.
At Kiva Sales & Service (KSS), we take pride in pioneering California's cannabis distribution sector. As the exclusive distributor for Kiva Confections and a thoughtfully selected range of premium cannabis brands, we guarantee that dispensaries throughout the state have uninterrupted access to the products their customers cherish. Founded on the core values of quality, reliability, and innovation, we offer unmatched service through next-day deliveries, expert account management, merchandising support, and a comprehensive logistics network. Our team works tirelessly each day to elevate industry standards while empowering dispensaries to flourish in a dynamic market. Joining KSS means becoming part of a company that is dedicated to delivering excellence and fostering sustainable growth within the cannabis industry.
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.
The Associate Director of Operational Procurement is crucial in driving the effective and economical procurement of goods and services within Penumbra Inc. This leadership role oversees the procure-to-pay process, raw material planning, and source-to-contract initiatives across key categories. This individual is tasked with ensuring adherence to corporate policies, procurement systems, and legal standards while continuously enhancing procurement strategies. By collaborating effectively with various departments, they forecast requirements and strategically plan procurement activities, utilizing strong analytical skills and a collaborative leadership approach. Exceptional written and verbal communication skills are essential, as this role requires the ability to present executive summaries and in-depth analyses. Key Responsibilities• Develop and execute processes to meet forecast requirements for finished goods and raw materials, managing inventory and optimizing ordering cycles across direct and indirect categories to ensure availability.• Lead, mentor, and foster the Operational Procurement team, providing resources and guidance to ensure efficient task execution and high-quality outcomes, while addressing escalations as necessary.• Formulate and enforce Operational Procurement policies, practices, standards, and procedures, ensuring they align with Penumbra values and are adhered to consistently.• Utilize ERP, MRP, P2P, and analytics systems for raw material planning and order management.• Identify and implement improvements in procurement practices, driving compliance with standardized processes across the Operational Procurement function.• Assist in designing, documenting, and executing raw material forecasting and order management processes for key suppliers and critical components, including indirect spending and sub-contracting.• Conduct supplier capacity assessments and internal requirement analyses, collaborating with Strategic Procurement, engineering, quality, and production teams to resolve supplier-related issues.• Develop strategies to mitigate risks associated with service and component supply disruptions to minimize business impact.• Support procurement stability for new products transitioning from development to commercialization.• Recognize trends and opportunities for procurement enhancement through cross-functional collaboration and industry engagement, thereby informing best practices and continuous improvement.
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.
Sila Nanotechnologies creates advanced battery materials designed to boost energy density while making batteries lighter and smaller. The company’s work supports cleaner energy by improving lithium-ion batteries used in consumer electronics and electric vehicles. By making batteries more efficient, Sila aims to help reduce reliance on fossil fuels and drive innovation in energy storage. Role overview The Senior Manager of Battery Engineering leads a team dedicated to bringing Sila’s lithium-ion battery technologies to market. This position manages the rollout of new materials for consumer, industrial, and automotive uses. Collaboration is central to the role, involving work with cell suppliers, OEMs, and teams across technical and business functions at Sila. What you will do Lead and mentor a team integrating Sila’s anode materials with customer products Serve as a player-coach, balancing hands-on technical work with team guidance Coordinate projects between internal groups and external partners Set up clear systems and responsibilities to keep projects on track Encourage teamwork to reach challenging but realistic goals Requirements Experience managing engineering teams in battery technology or related areas Deep technical knowledge of lithium-ion batteries Comfort working across disciplines and with outside partners History of contributing technically while leading others Strong communication and organizational skills Location Alameda, CA
Full-time|$189K/yr - $243K/yr|On-site|Alameda, California, United States
THE COMPANYSaildrone Inc. is a pioneering maritime defense firm and the leading global provider of autonomous unmanned surface vehicles (USVs). With unparalleled operational experience and extensive ocean miles, Saildrone’s combat-deployed systems play a crucial role in supporting national security and force projection worldwide, operating 24/7/365.Headquartered in Alameda, CA, Saildrone also has business development and sales operations in Washington, DC, along with deployment hubs across Europe and the Middle East. By harnessing advanced technologies such as autonomous operations, edge computing, and renewable energy, Saildrone is redefining the future of naval operations. Join a dynamic, mission-oriented team at the forefront of maritime security and autonomous innovation.THE POSITIONWe are seeking a Senior Manager of Mechanical Engineering to join our Hardware Engineering team. Reporting directly to the Head of Hardware Engineering, you will be responsible for leading the mechanical design and implementation of critical systems throughout Saildrone’s autonomous fleet. Your contributions will significantly influence vehicle reliability, manufacturability, and performance during long-duration ocean missions.We are looking for a seasoned technical leader who blends extensive mechanical engineering knowledge with a disciplined approach to execution, clarifying complex requirements, and fostering teams that deliver scalable, production-ready systems.THE TEAMThe Mechanical Engineering team is tasked with designing, integrating, and sustaining electro-mechanical systems for Saildrone’s unmanned surface vehicles. Our goal is to provide robust, manufacturable hardware that functions reliably in extreme maritime conditions, enabling continuous maritime domain awareness in national defense.THE RESPONSIBILITIESMechanical System Design: Spearhead the design of electro-mechanical sub-assemblies including actuation (servos), propulsion, structures (composites), and environmental enclosures to achieve performance, reliability, and maritime survival objectives.BOM & Configuration Management: Oversee the complete vehicle Bill of Materials for all sensor configurations, ensuring precision in part numbering, revision control, and assembly detailing.Cross-Functional Integration: Collaborate closely with Electrical, Firmware, and NPI teams to coordinate on PCBA enclosures, thermal management paths, and sensor placements to ensure cohesive system functionality.
Full-time|$199.5K/yr - $256.5K/yr|Hybrid|Alameda, California, United States
ABOUT SAILDRONESaildrone is a pioneering maritime defense firm and the foremost authority in autonomous unmanned surface vehicles (USVs). With unparalleled operational experience and ocean miles logged, Saildrone actively supports national security and force projection globally, around the clock.Headquartered in Alameda, CA, our manufacturing and R&D center is complemented by business development and sales operations in Washington, DC, and deployment hubs across Europe and the Middle East. By integrating advanced sensing, renewable energy, and cutting-edge unmanned surface technology, Saildrone is revolutionizing naval operations. Join our dynamic, mission-oriented team to drive innovation in maritime security.POSITION OVERVIEWWe are in search of a Senior Manager to steer our Vehicle Infrastructure team. Reporting directly to the Director of Software Engineering, you will champion your team’s development while ensuring the successful execution of the roadmap, aligning with software, firmware, and hardware teams, as well as overarching business goals. We seek a technical leader who thrives in ambiguity, drives engineering excellence, and fosters high-performing teams in fast-paced, mission-critical settings.This role requires you to be onsite in Alameda, CA, for three days a week as part of our hybrid model. Remote work is not an option.TEAM RESPONSIBILITIESThe Vehicle Infrastructure team is tasked with integrating Linux OS and driver code for core and payload computing on the drone, working with Nvidia embedded systems, managing satellite and wireless communications, and deploying onboard IP networking strategies, as well as system configuration management for computer and networking hardware.KEY RESPONSIBILITIESOnboard Infrastructure Delivery: Direct the design, development, and deployment of onboard software and networking infrastructure, ensuring Linux OS and driver integration achieves performance and reliability benchmarks.System Architecture: Oversee the architecture of the onboard software stack, including responsibility for IP networking strategies, optimizing multi-egress routing, and managing system configurations.Cross-Functional Coordination: Collaborate with Technical Program Management, Hardware, and Firmware teams to align Technical Roadmaps and ensure successful delivery of projects.
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.
