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Experience Level
Experience
Qualifications
Preferred qualifications include experience with Veeva Document Control and Training Modules, as well as a keen understanding of quality management systems and regulatory compliance.
About the job
The Document Control & Training Specialist will play a critical role in overseeing Document Control processes at GeneFab while also executing essential training initiatives to enhance our Training Program. This position will involve advancing and implementing document management protocols, alongside performing administrative tasks using Veeva QualityDocs to ensure compliance with GxPs and Good Documentation Practices. Additionally, the Specialist will manage training-related activities within our Learning Management System (Veeva Training) as required. The role necessitates close collaboration with internal teams, including Quality Assurance, Quality Control, MSAT, Manufacturing, and Supply Chain.
About GeneFab
GeneFab is a leading biotech company dedicated to advancing the field of genetic engineering through innovative solutions and a commitment to quality and compliance in all aspects of our operations. Our team thrives on collaboration and is driven to maintain the highest standards in the industry.
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 wil…
Join genefab as a Controller, leading our financial operations from our headquarters in Alameda, CA. This role requires frequent collaboration with our Taipei, Taiwan headquarters. We are looking for a dynamic finance professional who is ready to take on new challenges!
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 Document Control & Training Specialist will play a critical role in overseeing Document Control processes at GeneFab while also executing essential training initiatives to enhance our Training Program. This position will involve advancing and implementing document management protocols, alongside performing administrative tasks using Veeva QualityDocs to ensure compliance with GxPs and Good Documentation Practices. Additionally, the Specialist will manage training-related activities within our Learning Management System (Veeva Training) as required. The role necessitates close collaboration with internal teams, including Quality Assurance, Quality Control, MSAT, Manufacturing, and Supply Chain.
genefab seeks a Senior Process Engineer to join the Manufacturing Science and Technology (MSAT) team in Alameda, CA. This role centers on refining manufacturing processes and safeguarding product quality. Role overview The Senior Process Engineer leads efforts to enhance manufacturing operations. The position involves reviewing and optimizing workflows to improve efficiency and consistency in production. What you will do Lead projects aimed at improving processes throughout manufacturing Analyze operational data to spot trends and suggest actionable solutions Collaborate with cross-functional teams to put changes in place and address challenges Requirements Proven experience in process improvement within a manufacturing environment Strong analytical and problem-solving abilities Comfort working with teams from various disciplines
genefab is seeking a Senior Manufacturing Engineer based in Alameda, CA. The role centers on designing, implementing, and refining manufacturing processes. The main goal is to enhance product quality and boost efficiency within the engineering group. Key responsibilities Create manufacturing processes for both new and existing products Drive improvements that increase process efficiency Streamline workflows to help maintain consistent product quality Role impact This position plays a key part in shaping genefab’s manufacturing approach. The Senior Manufacturing Engineer’s knowledge directly supports the company’s mission and ongoing innovation efforts.
Join genefab as a CRDMO Program Lead, where you will be at the forefront of advancing our contract research and development services. In this pivotal role, you will oversee the planning, execution, and management of critical programs, ensuring alignment with client objectives and regulatory requirements. Your expertise will drive innovative solutions and enhance our operational efficiency.
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
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.
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.
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.
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.
Full-time|$201.1K/yr - $266.5K/yr|On-site|Alameda, California, United States
ABOUT SAILDRONESaildrone is a pioneering maritime defense company recognized as the global leader in autonomous unmanned surface vehicles (USVs). With an unmatched operational track record, Saildrone's systems are actively deployed in combat scenarios, providing support for national security and force projection on a global scale, 24/7/365.Located in Alameda, CA, our manufacturing and R&D facilities are complemented by business development and sales operations in Washington, DC, and deployment hubs across Europe and the Middle East. By leveraging cutting-edge autonomous operations, edge computing, and advanced sensing technologies, Saildrone is redefining the future capabilities of naval operations. Become part of a dynamic, mission-driven team that is at the forefront of maritime security and technological innovation.POSITION OVERVIEWWe are currently in search of a Corporate Controller to join our Finance team. Reporting directly to the Chief Financial Officer, you will be instrumental in developing and scaling Saildrone’s accounting function, ensuring precise financial reporting, robust controls, and operational excellence in our rapidly expanding global organization. We seek a proactive leader capable of simplifying complexity, instilling process discipline, and enhancing technical operations—from payroll to production costing—while facilitating growth.TEAM DYNAMICSThe Finance team plays a crucial role in upholding Saildrone’s financial integrity, enabling the company to efficiently scale its manufacturing, operations, and global deployments. We collaborate closely with engineering, manufacturing, supply chain, and operations to provide reliable financial insights that underpin mission-critical initiatives within the national security and defense sectors.KEY RESPONSIBILITIESFinancial Reporting: Oversee month-end and quarter-end close processes to produce timely and accurate financial statements (P&L, Balance Sheet, Cash Flow) in compliance with U.S. GAAP.Operational Accounting: Ensure accountability for the general ledger, chart of accounts, internal controls, and payroll operations.Compliance & Audit: Lead annual financial audits, oversee tax filings, and maintain regulatory compliance. Support DCAA/DCMA reviews, guaranteeing adherence to FAR/CAS standards in defense-related accounting practices.Cost Accounting & Inventory: Collaborate with Manufacturing and Supply Chain to ensure precise accounting for Work In Progress (WIP), Capital Expenditures (CapEx), and inventory management.
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 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...
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.
Full-time|$199.5K/yr - $256.5K/yr|Hybrid|Alameda, California, United States
THE COMPANYSaildrone Inc. stands at the forefront of maritime defense as a global leader in autonomous unmanned surface vehicles (USVs). With unmatched ocean miles and operational expertise, Saildrone actively deploys systems that bolster national security and force projection worldwide, 24/7/365.Our headquarters for manufacturing and R&D are located in the vibrant city of 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 technologies, and renewable energy, Saildrone is redefining the operational capabilities of the Navy of the future. Join us in a dynamic, mission-driven environment where innovation in maritime security thrives.THE POSITIONWe are on the lookout for a Senior Manager, Vehicle Control Software to join our Software Engineering team. In this pivotal role, you will report directly to the Director of Software Engineering, taking charge of the robotics software stack that drives our autonomous surface vehicles. You will ensure that our roadmap execution aligns seamlessly with both technical and business objectives. We seek a technical leader who excels in clarifying ambiguity while balancing hands-on expertise with team leadership in a fast-paced setting. This role initially focuses on individual contributions to foster deep system familiarity, progressing towards a balanced mix of technical input and team leadership.This position requires onsite presence in Alameda, CA, three days a week as part of our hybrid model. Remote work is not an option.THE TEAMThe Robotics Software Engineering team is tasked with creating the software systems that empower Saildrone’s autonomous fleet to function in the most isolated maritime environments on Earth. Our mission centers on delivering robust and scalable vehicle systems software to enhance global maritime domain awareness, operating within a national security and defense framework.THE RESPONSIBILITIESLead the development of the vehicle systems software stack to ensure reliable, high-performance capabilities meet quality, safety, and customer standards.Actively contribute to architecture and design reviews while managing a team of engineers to ensure effective roadmap execution.Oversee the development and implementation of the vehicle systems roadmap, including planning, resource allocation, and execution against defined business goals.
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.
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.
