Quality Operations Lead — Medical Devices (FDA-Regulated)
NCSL International
NCSL International is seeking an Operations Quality Manager in Fremont, CA, to oversee the Quality Operations team. This includes managing quality assurance activities, compliance with regulatory requirements, and ensuring top product quality for Philips' Image Guided Therapy Devices. The ideal candidate has extensive experience in FDA regulated environments, strong leadership skills, and knowledge of quality metrics. Benefits include comprehensive rewards, PTO, and retirement plan contributions. #J-18808-Ljbffr NCSL International
$103k - $163.97k
A leading health technology company located in Fremont, CA is seeking an Operations Quality Manager to manage the Quality Operations team. The role involves implementing quality... ...have at least 5 years of experience in FDA regulated environments and a Bachelor's degree in a...QualityMedical device- Philips is seeking an Operations Quality Manager in Fremont, CA to oversee the... ...for Image Guided Therapy Devices. The role involves managing product quality, leading audits, and implementing continuous... ...5 years of experience in FDA regulated environments, strong leadership...QualityMedical device
- A leading medical device company in California is seeking an experienced professional to lead Quality Assurance and Regulatory Affairs teams. This role requires 15+ years of experience... ...candidate will manage compliance with FDA regulations and direct quality initiatives....QualityMedical device
$32 - $38 per hour
...with all GMP manufacturing operations, including working with engineers... ...performing in-process and quality testing related to product... ...understanding of cGMP, DEA and OSHA regulations • Good mechanical aptitude... ...in the biopharmaceutical or medical device industry ~ AA or AS in...QualityMedical deviceFlexible hoursShift work$91.9k - $130k
...wide variety of cutting-edge medical products, laboratory equipment... ...equipment, and other devices. Complete investigations by analyzing... ...client visits. Performs quality systems and technical audits... ...navigate changing standards and regulations, so they can provide people...QualityMedical deviceFull timeWork at officeShift work- ...Program Manager leads/supports Cytek Product... ...Project Scope, Quality, Cost, and Timing... ...to business operations including IT programs... ..., Diagnostic or Medical Device industries. At... ...III products (for FDA submission) (... ...and International regulations and standards that...QualityMedical device
- ...Automotive, Consumer Goods and Medical Device Industry. The company... ...high-volume stamping operation, with proven... ...Tool & Die, adeptness in leading cross-functional teams... ...Members, Tool & Die Team, Quality and Manufacturing Team... ...set up controls to regulate machining factors such...QualityMedical deviceRelocation package
$121.26k - $126k
...at 6:59 AM The Quality Engineer II is responsible... ...other relevant FDA and International regulations. Specific duties... ...and Class III devices through dose... ...of reusable medical devices; (6) providing... ...Controls; (7) leading as a QA... ...Qualification (IQ), Operational Qualification (OQ...QualityMedical deviceFull timeLocal area- ...with the company's Quality System and... ...expertise in the daily operation and maintenance of... ...May be required to lead or contribute to the... ...or clearance by FDA or other international... ...experience in the medical device industry.... ...Knowledge of FDA regulations, guidelines, and policy...QualityMedical deviceContract workWork at office
$22 - $27 per hour
...Shipping, Receiving & Packaging Operator i s responsible for... ...works closely with Production, Quality, Planning, and Shipping departments... ...for thesemiconductor and medical device industries. Shift : Mon -... .... Experience handling regulated o r high-precision products...QualityMedical deviceHourly payLocal areaShift work- ...technologies are used by leading memory and logic, analog /power device manufacturers... ...DNA, will continue to operate as a global, market-driven... ...with operations, quality, and design engineering... ...high-volume or highly regulated industries (e.g., medical device, aerospace,...QualityMedical deviceWorldwide
- ...SUMMARY The Manager, Quality Assurance is responsible for leading and ensuring the... ...This role provides operational and strategic... ...requirements, including FDA Quality Management System Regulation (21 CFR Part 820/... ...Assurance within the medical device or similarly...QualityMedical deviceWork experience placementWork at office
- ...and a solid understanding of regulated environments. **South Bay Area... ..., and manufacturing of medical devices. Create detailed CAD models... ...documentation in compliance with FDA and ISO standards (e.g. ISO13... ...cross-functionally with R&D, Quality, and Supplier Quality teams...QualityMedical deviceContract workRemote work
- WHAT YOU'D DO Quality Assurance: Provide... ...with FDA QMSR and ISO standards. Lead preparation and... ...multiple functions (Operations, R&D, Sales & Marketing... ...regulatory regulations/standards/... ...with FDA MDR and device vigilance reporting... ...of Moximed Medical Device Reports...QualityMedical deviceFlexible hours
- ...recognized for supporting complex, regulated environments and partnering... ..., biotech, pharmaceutical, medical device, and research organizations... ..., GxP environments, R&D, quality, manufacturing, and... ...relationships across R&D, clinical operations, manufacturing, quality, regulatory...QualityMedical deviceContract workWork experience placementRemote work
- ...Hardware Manufacturing Operations team, you will be a... ...responsible for overseeing quality control activities... ...procedures, and leading a team of technicians... ...Comply with safety regulations and the Zoox’s safety... ...Aerospace, Automotive, Medical Device, Robotic industry)....QualityMedical device
$23 - $27 per hour
...Quality Inspector About the company: Viant is a global medical device partner providing design, development,... ...Fremont, CA site is a leading hub for medical device... ...advanced clean room operations, the facility... ...manufacturing in a regulated environment. About...QualityMedical deviceHourly payLocal areaWorldwideMonday to FridayShift workDay shift$55 - $65 per hour
...while improving their overall quality of life. This full-time... ...documentation of services in the medical record. The SLP also provides... ...with state practice regulations. Communicate regularly with... ...medical equipment and adaptive devices to support resident independence...QualityMedical deviceHourly payFull timeFlexible hours- ...support warehouse and logistics operations at our client's facility in... ...experience working in a regulated warehouse environment, maintaining... ...to detail and commitment to quality. Basic computer and... ..., biotech, life sciences, medical device, or GMP-regulated environments...QualityMedical deviceHourly payContract workWork at officeMonday to Friday
- ...JOB SUMMARY The Quality System Engineer is... ...requirements, including FDA Quality Management System Regulation (21 CFR Part 820/... ...Assurance in the medical device field. ~ Working... ...CQA, or ISO 13485 Lead Auditor certification... ...stationary position and operate office equipment...QualityMedical deviceWork experience placementWork at office
- ...Therapeutics in Union City, CA, seeks a Quality Engineer to lead continuous improvement in testing... ...Quality Engineering, preferably in medical devices, and a degree in engineering or a related... ..., ensuring compliance with regulations, and analyzing data for product improvement...QualityMedical device
$121.26k - $126k
A leading medical device company is seeking a Quality Engineer II in Fremont, CA. Responsibilities include maintaining quality compliance, planning sterilization validations, conducting risk evaluations for implantable devices, and overseeing product development for Class...QualityMedical device- ...Job Description Job title: Quality Engineer I Location:... ...effectiveness of Client medical products. · The Analyst will... ...complaints to comply with current FDA and international reporting regulations. · Duties also include... ...I, II, and III medical devices regarding Medical Device...QualityMedical device
$25 - $28 per hour
...CA 94538 Department: Operations Mfg Techs Worker Category... ...Industry: Neurovascular Medical Devices (Catheters) Function: Assembly... ...to meet safety and high-quality standards. We're looking... ...and consistently follow FDA Quality Systems Regulations and ISO 13485 Assists...QualityMedical deviceHourly payFull timeMonday to FridayFlexible hoursShift work$33.74 - $41.96 per hour
...Abilities: Preferred: Working knowledge of medical device/supply terminology. Essential Job... ..., evaluate, demonstrate initiative, quality of work, productivity - Accurately checks... ...EMTALA, HIPAA, and other services specific regulations. Performs other related duties....QualityMedical deviceDaily paid$85k - $95k
...Fremont, California, is looking for a QA Specialist to assist in managing the Quality Management System. Candidates must have a Bachelor's degree and 3-5 years of quality experience in medical devices or biotech, along with strong knowledge of GCLP and GCP. Key...QualityMedical device- ...Engineer for Software Design Quality to work onsite in... ...role involves ensuring that medical devices meet design control requirements... .... Responsibilities include leading software quality assurance... ...Engineering, alongside knowledge of FDA regulations. #J-18808-Ljbffr Abbott...QualityMedical device
$45 - $75 per hour
...opportunity with one of our clients, a leading life sciences company in the Bay Area.... ...pioneer progress in the biotechnology and medical device industries. Workplace: Onsite in... ...with GMP/GLP laboratory practices and quality systems is advantageous. Exposure to...QualityMedical deviceHourly payContract work- ..., California. This role includes ensuring quality standards are met, leading complaint handling processes, and supporting... ...has over five years of experience in medical devices, a BA/BS degree, and knowledge of FDA regulations. This position requires strong analytical...QualityMedical device
- ...4 years of experience in the medical device manufacturing industry, specializing in supporting regulated production environments. Experienced in manufacturing operations, process validation (IQ/OQ/PQ... ...while ensuring compliance with quality and regulatory standards....QualityMedical device
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