IVD QMS Compliance Manager - cGMP & Audits
Cytek Biosciences Inc
Cytek Biosciences Inc is seeking a QMS Compliance Manager to lead the implementation of a compliant, scalable IVD cGMP Quality Management System. Responsibilities include developing SOPs, overseeing internal audits, and supporting FDA compliance activities. This role requires a hands-on leader with extensive experience in GMP regulations and an ability to drive organizational change towards a compliant cGMP environment. Applicants should have a relevant degree and 8+ years of experience in a GMP-regulated setting. #J-18808-Ljbffr Cytek Biosciences Inc
- ...your opportunity. Role Overview The QMS Compliance Manager is a hands‑on leader responsible for building... ...and sustaining a compliant, scalable IVD cGMP QMS across Cytek facilities. The role... ...operations, ensuring readiness for audits and long‑term regulatory compliance....SuggestedShift work
- Cytek Biosciences in Fremont is seeking a QMS Compliance Manager to lead the development and implementation of a compliant IVD cGMP Quality Management System. This role requires... .... Responsibilities include conducting audits, developing SOPs, and ensuring readiness for...Suggested
- Stryker Corporation is seeking a Manager, Financial Compliance in Fremont, California. This hybrid role involves managing accounting systems and providing... ...strategic support. Responsibilities include coordinating audits, ensuring compliance with GAAP, and performing financial...Suggested
$191k - $202k
...the Quality Assurance (QA) team and directing overall GxP compliance for our bioprinted tissue therapeutics. You will be accountable... ...and maintain a phase-appropriate, GMP compliant Quality Management System (QMS) across all development and manufacturing activities. Own...SuggestedLocal area- ...understand how to build automation that scales with the product. You will bring structure to our testing strategy, own our test management processes in Qase, and ensure quality is embedded into our development lifecycle rather than treated as a final checkpoint. Your...SuggestedContract workRemote workFlexible hours
$100k - $120k
...Summary An experienced Quality Assurance Manager who will play a pivotal role in ensuring... ...and supports supplier and internal audit functions, validation and calibration activities... ..., documentation system, and all compliance/regulatory responsibilities. Duties/Responsibilities...Full timeWork experience placement- ...requires 15+ years of experience in medical device quality assurance and strong leadership skills. The successful candidate will manage compliance with FDA regulations and direct quality initiatives. Candidates with experience in orthopedic medical devices will be...
- ...existing Quality Assurance team including managers and individual contributors. Assume... ...support commercial activities and ongoing compliance, including complaint tracking, investigation... ...action. Supervise and manage internal audits and inspections including FDA, Cal FDB...Flexible hours
- ...to a disability, contact this employer to ask for an accommodation or an alternative application process. IMPORT / EXPORT & COMPLIANCE MANAGER Full Time Fremont, CA, US 17 days ago Requisition ID: 1045 Optoma Technology, Inc. is a leading manufacturer of award-winning...Full time
- Optoma Corporation in Fremont, CA is seeking an Import/Export & Compliance Manager to enhance operational practices in 3rd party warehouse management, sales support, and inventory management. As a key player in our logistics strategy, the successful candidate will ensure...
- Overview Workday Testing Lead — Experience: 10-12 years Skills: All modules Job Description: Manages testing activities for Workday implementations. Responsibilities Develop test strategies and scripts. Coordinate UAT, regression, and end-to-end testing. Mentoring & Leadership...
- A leading technology firm in California is seeking an experienced Workday Testing Lead to oversee testing activities for Workday implementations. The ideal candidate has 10-12 years of experience and is proficient in all Workday modules. Responsibilities include developing...
$104k - $231k
...makeWithin the Global Products Group, the Product Regulatory Compliance Organization is dedicated to the successful implementation and... ...portfolio throughout the product lifecycle.As a Technical Program Manager at Lam, you will lead cross-functional regulatory compliance...Local areaRemote workFlexible hours2 days per week3 days per week1 day per week- SOS Meals on Wheels is hiring a Grant Administrator responsible for managing and organizing the grant portfolio, ensuring grant compliance, and serving as the main point of knowledge for all grant-related activities. You will work closely with the Development team and...
$190k - $250k
...performing and field‑proven optical solutions from components, modules to integrated line‑cards. We provide cutting edge wavelength management and amplifier technologies. Our comprehensive optical, mechanical, electrical and software integration capabilities enable us to...Flexible hours$230k
...Director, Regulatory Affairs Manage all regulatory activities for the company. Work with partners representing company interests... ...Direct regulatory activities for maintenance and continued compliance of commercial product(s). Work with partners on their regulatory...- ...Tax Manager (Public Accounting) Company: GlobalCFO, LLC Location: Fremont, CA Reporting To: VP - Tax Experience: 6+ years... ...integration of the tax accounting and international tax compliance processes. Self-initiate research and is resourceful in their...Worldwide
$230k
Nova Pneuma, Inc. in Fremont, CA seeks a Regulatory Manager to oversee regulatory strategies and submissions for product candidates. The ideal candidate will manage regulatory compliance from pre-IND through approval while liaising with project teams and regulatory authorities...$159k
...Operations / Strategy Job Level: Senior Manager Business Unit: Strategy & Growth... ...Department Overview: The Electric Risk & Compliance organization provides governance,... ...rhythms; and ensuring documentation and audit trails support regulatory requirements....Contract workWork experience placementWork at officeFlexible hours2 days per week3 days per week- ...customer service skills and experience in research regulatory compliance, specifically with review boards: institutional review boards... ...reviews of human subject and animal subject protocols, including management of Institutional Review Board (IRB) committee, Institutional...Work at officeRemote workFlexible hoursNight shift
$240k - $334k
...in Fremont, CA. This role requires leading a team through the post‑silicon lifecycle, developing efficient ATE test programs, and managing high‑frequency testing projects. Candidates should possess a Bachelor's degree in Electrical Engineering or a related field and extensive...- Raxium, located in Fremont, California, is looking for a highly experienced Test Engineer with over 10 years of experience in Test Engineering and Post-Silicon Validation. Candidates should hold a Bachelor's degree in Electrical Engineering or a related field, with preferred...
$240k - $334k
...Experience with benchtop measurement equipment such as high‑bandwidth oscilloscopes, spectrum analyzers, BERTs and VNAs. Vendor management experience working with OSATs and PCB fabrication houses. Familiarity with high‑speed serial protocols (MIPI). Proven track record...$240k - $334k
...architecture. Experience with benchtop measurement equipment (High-bandwidth Oscilloscopes, Spectrum Analyzers, BERTs, VNAs). Vendor management experience working with OSATs and PCB fabrication houses. Familiarity with high-speed serial protocols (MIPI). Proven track...- ...of engineers and ensure zero-defect quality. The ideal candidate has extensive experience in test engineering, CMOS, and vendor management. A Bachelor's degree in a relevant engineering field is required, and mastery in C++/Python is beneficial. Join Google to innovate...
$105k - $130k
Air Liquide USA LLC in Fremont, CA is seeking a Quality Operations Supervisor to manage quality assurance and control initiatives. The role involves engaging with the Quality team, implementing internal processes to meet quality requirements, and leading investigations...- ...communication skills, the ability to influence senior leadership, and a strategic mindset that balances scientific rigor, regulatory compliance, and commercial impact. Hiring Manager Title SVP, Chief Regulatory Officer Functions Legal Operations...
- Compliance Manager - Global Lab Environment US - Milpitas About us Graphcore is one of the world’s leading innovators in Artificial Intelligence compute. It is developing hardware, software and systems infrastructure that will unlock the next generation of AI breakthroughs...Contract workFor contractorsFor subcontractorWork at office
$230k
...0 Dumbarton Cir Fremont, CA 94555, USA Manages all regulatory activities for the company... ...with project teams to ensure regulatory compliance throughout the product development and... ...reporting, DSUR, PSUR, REMS Annual Reports and audits), product approval process, and post‑...$94.22k - $157.03k
...important role of strengthening the company's compliance programs, with focus on J-SOX and KIOXIA Group internal audits. The focus of this role is to strengthen company... ...logical access controls Participate in management of the J-SOX program from planning through...Local areaWorldwideFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to IVD QMS Compliance Manager - cGMP & Audits. Be the first to apply!
- regulatory affairs director Fremont, CA
- compliance director Fremont, CA
- regulatory manager Fremont, CA
- regulatory & compliance manager Fremont, CA
- head compliance Fremont, CA
- compliance manager Fremont, CA
- manager regulatory affairs Fremont, CA
- vp compliance Fremont, CA
- regulatory affairs Fremont, CA
- compliance audit Fremont, CA

