Senior Quality Engineer — Medical Devices & Compliance
pulsebiosciences
Pulse Biosciences in Hayward, CA is seeking a Principal Quality Engineer to lead quality systems for CellFX medical devices, ensuring compliance with 21 CFR 820 and ISO 13485. You will guide design controls, risk management, biocompatibility testing, sterilization, and regulatory submissions, collaborating with R&D, manufacturing, and regulatory affairs. Bachelor's in engineering or related field required; medical device quality leadership preferred; strong analytical and communication skills. #J-18808-Ljbffr pulsebiosciences
- Mizuho OSI is seeking a QA Engineer to lead quality assurance activities and ensure compliance with FDA QMSR, ISO 13485, and EU MDR for capital equipment and accessories. The role supports manufacturing, design validation, and continuous improvement initiatives across cross...Senior
- Pulse Biosciences, Inc. is seeking a Principal Quality Engineer to lead quality systems (QSR 21 CFR 820; ISO 13485) for CellFX System, surgical disposables, and reusable medical devices. You will guide product development and manufacturing with robust design controls,...Suggested
- XII Medical, Inc. is seeking a Senior Mechanical Engineer to lead the design, development, and validation of mechanical components for durable medical equipment... ...to ensure performance, safety, and regulatory compliance. The role requires strong mechanical fundamentals,...Senior
- Penumbra, Inc. in Alameda, CA, is seeking a Development Quality Engineer I to work with product development teams to design and qualify new... ...system elements to ensure high quality and regulatory compliance, and help bring products safely and efficiently to market. The...Suggested
- Penumbra, Inc. in Alameda, CA, is seeking a Senior Development Quality Engineer to lead Quality Engineering within a... ...development team, design and qualify new life-saving devices, implement design control, and ensure QMS compliance. You will drive audits, support FDA...Senior
- Mizuho OSI is seeking a Senior Manager, Quality Assurance Engineer to lead the QA Engineering group and ensure compliance with regulatory requirements. This role reports to the Senior Director of Quality Assurance and Regulatory Affairs and oversees budgeting, staffing,...
- Epia Neuro in Alameda, CA seeks a senior electrical hardware engineer to own and evolve electrical architecture and hardware across implantable... ...research prototypes move toward production‑intent Class III medical devices, coordinating technical decisions and documentation...Senior
- ...in Alameda, California, seeks a Senior Industrial/Continuous Improvement Engineer to lead Lean initiatives that optimize... ...with manufacturing, quality, and R&D to implement improvements... ...Mechanical Engineering and 4+ years in a medical device #J-18808-Ljbffr Penumbra, Inc.Senior
- ...Posted: 2026-10-18Penumbra, Inc. in Alameda, CA seeks a Senior Supplier Quality & Compliance Analyst to manage external supplier audits, evaluate... ...science degree and 7+ years in quality systems within medical devices, plus experience with NCRs, CAPAs, and supplier quality...Senior
- ...seeking a seasoned mechanical design engineer to lead new medical device development and design transfer.... ...functional programs with Operations, Quality, and Regulatory teams. The role... ...for manufacturability, regulatory compliance (FDA ISO 13485), and robust design...Senior
- Abbott Diabetes Care in Alameda, CA is seeking a Process Engineer III to support manufacturing equipment and processes. This role drives cost reductions, improves quality, and scales production in a regulated setting. You will design, verify, and validate processes, lead...Senior
- Mizuho OSI in Union City, California is seeking a Mechanical Engineer to design operating room equipment and drive trains for patient positioning. You will work with manufacturing, marketing, quality, and regulatory teams to develop specifications, prototypes, and production...Senior
- Abbott Diabetes Care in Alameda, CA is seeking a Process Engineer III to support new and existing equipment and processes used in manufacturing... ...will lead upgrades, drive cost reductions, and improve product quality in a cross-functional setting. This onsite role requires a BS...SeniorShift work
- Lucid is seeking a Sr Automation Engineer, Test and Validation to join the LV Test & Validation group. You will design automated tests for DVT and compliance, and develop an integrated automated test system for environmental and electrical testing. The role requires strong...Senior
- ...Skydio is seeking a highly motivated Senior Process Engineer to lead the development, implementation... ...to support safe, efficient, and high-quality production. Drive New Product... ...of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at . How do...SeniorFull timeContract workFor contractorsFor subcontractorWork at officeLocal areaRelocation packageShift work
- Bayside in Fremont is seeking a Principal Process Engineer to join their growing team. The role focuses on ensuring process equipment... ..., cell culture, and SAP. Expect responsibilities in compliance, quality, and continuous process optimization. #J-18808-Ljbffr BaysideSenior
$161k - $222k
...Quality Engineer The Quality Engineer will interact with Corporate Quality, Field Quality, Manufacturing, Design Engineering, and fleet... ...develop and review of PFMEA and Control Plans to ensure compliance and robust risk mitigation strategies for all critical manufacturing...SeniorContract workTemporary workRelocation package- Cepheid, a Danaher operating company, seeks a Senior Automation Controls Engineer to design, develop, and support PLC-based automation and machine... ...functional teams to ensure reliable equipment performance and compliance. Responsibilities include programming PLC/HMI,...Senior
$164k - $209k
...manufacturing equipment. The engineer partners with cross-... ...manage risk, maintain product quality, and drive continuous process... ...interpersonal skills Well versed in medical device regulatory requirements from... ...CAPA Experience working in compliance with GMP and GDP regulations...Senior- Lyten is seeking a Supplier Quality Engineer to drive quality assurance across the direct material supply base. You will own supplier nonconformances and lead root-cause investigations, working with internal teams and external partners. Your role will require strong QMS...Senior
- ...glucose monitoring technologies and drive strategic regulatory initiatives. You will lead and develop high-performing teams, interface with agencies, and drive regulatory submissions for US and EU, ensuring compliance and timely approvals. #J-18808-Ljbffr Thornton TomasettiSenior
- ...is seeking an experienced Senior Regulatory Affairs Specialist to support a leading medical device organization in Alameda, CA... ...device submissions, ensuring compliance across product lifecycle.... ...experience and will partner with Quality, Engineering, Manufacturing, R&D, and...Senior
- LHH is seeking a Senior Regulatory Affairs Specialist in Dublin, California to support global regulatory strategies for medical devices. The role involves preparing submissions, leading communications... ...regulatory agencies, and ensuring compliance with evolving regulations. The...Senior
- Abbott is seeking a Quality Engineer III for a 12-month onsite assignment in Alameda, CA. You... ...Affairs to ensure regulatory compliance and product quality. The role emphasizes... ...guidance to analytical methods across medical devices and diagnostics. #J-18808-Ljbffr AbbottSenior
$106k - $159k
...across the U.S. and Europe and expanding our team of engineers, scientists, and innovators. Supplier Quality Engineer Lyten is looking for an experienced... ...employee relocation plan (if applicable). Export/ITAR Compliance Disclosure Certain positions within Lyten, Inc....Local areaRelocation- Mizuho OSI, a leader in specialty surgery and patient positioning, is hiring a Senior Manager, Quality Assurance Engineer (QAE) to lead the Quality Department and drive regulatory compliance across ISO/QSR standards. The role reports to the Senior Director of QA and Regulatory...Senior
$43.08 - $71.81 per hour
...professional internal auditing and consulting work, which includes conducting and substantially leading operational, financial, and compliance engagements. Provides input and assists in developing the Annual Internal Audit Plan. Maintains all organizational and...SeniorFull time- Ultra Clean Technology in Hayward, CA is seeking a Senior Manager, Internal Audit to lead the SOX program, run risk-based audits, and partner with executives to strengthen internal controls across global operations. You will manage co-sourced teams, drive assurance over...Senior
- Morgan Advanced Materials is hiring a Senior Quality Inspector in Hayward, CA. You will inspect... ...and support production teams to ensure compliance with AS9100D. The role requires reading... ...worker who collaborates with Quality Engineers will thrive here. #J-18808-Ljbffr Morgan...Senior
- ...Transportation LLC seeks a Transportation Supervisor to lead the wheelchair transport team, overseeing routing, staffing, and safety compliance for PACE participants. The role requires coordinating with dispatch, center staff, and leadership to deliver dignified, on-time...Senior
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