Quality Systems Engineer: CAPA & Regulatory Compliance
THINK Surgical
THINK Surgical is seeking a Quality System Engineer in Fremont, CA, responsible for supporting the Quality Management System (QMS). You will ensure QMS processes align with regulatory standards, maintain procedures, and support audits. The ideal candidate has a Bachelor’s degree in engineering or science, 3–6 years in Quality Assurance within the medical device sector, and strong skills in CAPA and compliance. This role is crucial to maintaining product quality and patient safety. #J-18808-Ljbffr
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Quality Systems Engineer: CAPA & Regulatory Compliance in Fremont, CA vacancy
- ...Quality Systems EngineerThe Quality Systems Engineer leads the development, maintenance, and continuous improvement of... ...Management System (QMS) while ensuring compliance with ISO 9001 and supporting... ...corrective and preventive action (CAPA) activities and root cause...Suggested
Slingshot Connections
Newark, CA1 day ago - ...The Quality System Engineer is responsible for supporting the implementation,... ...), with a primary focus on CAPA, Complaint Handling, Nonconformance... ...aligned with applicable regulatory requirements, including FDA... ...safety, and regulatory compliance. This position is based in...SuggestedWork at office
Think Surgical
Fremont, CA2 days ago $90k - $100k
...Fremont, CA is seeking a Quality Engineer to support high-... ...conformal coating quality, compliance, and continuous... ...manufacturing quality systems. The position offers... ...processes meet customer, regulatory, and internal... ...results, NCRs, DMRs, RCCA, CAPAs, SCARs, internal...SuggestedTemporary workAppleOne
Fremont, CA4 days ago$141k - $307k
...together, anything is possible. Product Regulatory Compliance Engineer Date: Sep 1, 2026 Location:... ...Chain, Legal, Government Affairs, Quality, Manufacturing, and Sustainability teams... ..., processes, metrics, and reporting systems to improve compliance effectiveness across...SuggestedLocal areaRemote workFlexible hours2 days per week3 days per week1 day per weekLam Research
Fremont, CA3 days ago$110k - $140k
...market. We are a global engine providing the end-to-... ...end-to-end mechanical systems manufacturing service.... ...for a motivated Senior Quality Engineer who wants to build... .... Support the CAPA program to facilitate the... ...review ECOs to ensure compliance to quality system. Estimate...SuggestedPermanent employmentWork experience placementLocal areaRelocationFlexible hoursSanmina
Fremont, CA2 days ago$121k - $191k
...The Senior Supplier Quality Engineer drives supplier quality... ...suppliers quality systems and manufacturing processes... .... Evaluate compliance to relevant electronics... ...root cause analysis, CAPA, and containment actions... ...industry standards and regulatory requirements relevant...Full timeTemporary workRelocation packageFlexible hoursAgility Robotics
Fremont, CA2 days ago$95k - $115k
...Quality EngineerBay Advanced Technologies, an Applied Fluid Power subsidiary... ...looking for a Quality Engineer to join our team in Newark, CA... ...support the Quality Management System (QMS) for ISO9001 and ISO13485... ...actions to complete 8D CAPA reporting to customers and enhance...Hourly payFull timeWork experience placementApplied Industrial Technologies
Newark, CA1 day ago$71k - $102k
...Solutions transforms complex engineering challenges into production reality... ...infrastructure. Supplier Quality Engineer Position Summary... ...manufacturing processes, quality systems, and problem-solving... ...corrective and preventive actions (CAPA), including root-cause analysis...Casual workFlexible hoursTD Synnex
Fremont, CA5 days ago$81.47k - $122.21k
...Advanced Materials and Joining - Engineering polymer and metal joining... ...comprehensive range of high-quality solutions and technical services... ...implementation of quality systems for a growing manufacturing operation... ...responsibilities including CAPA, root-cause analysis,...Local areaWorldwideElement Solutions
Fremont, CA1 day ago$90k - $100k
...job summary: Seeking a Quality Engineer for a high growth chemical manufacturing... ...the Quality Management System, meeting customer... ...on schedule. Audits & QMS Compliance: Lead internal audits, support... ...COAs to customers, and track CAPA, complaint, and action item...Permanent employmentTemporary workWork experience placementLocal areaImmediate startRandstad
Fremont, CA4 days ago$106k - $145.86k
...Supplier Quality Engineer The Supplier Quality Engineer... ...suppliers to ensure compliance with quality standards... ...supplier audits (process, system, and compliance) and... ...preventive actions (CAPA) with suppliers... ...) Support audits, regulatory requirements, and customer...Full timeMattson Technology
Fremont, CA3 days ago$43 per hour
...CA, to hire an experienced Quality Assurance Engineer (QA Engineer). Location: Fremont... ...9001 quality management systems, root cause analysis,... ...corrective and preventive actions (CAPA), and continuous... ...Responsibilities Support and maintain compliance with ISO 9001 Quality...Full timeContract workTemporary workLocal area- ...Quality Engineering ManagerUnigen is a global technology company providing... ...quality, quality systems compliance, and continuous improvement... ...consistently meet customer, regulatory, and company requirements.... ...Corrective and Preventive Action (CAPA) programs and ensure...
Unigen
Newark, CA3 days ago $130k - $150k
...Quality Engineering Manager FREMONT AREA, CA — 100% onsite Salary Range:$130,000–$150,0... ...expertise in root cause analysis, 8D, CAPA, and corrective action programs Experience... ...processes Knowledge of quality systems and compliance, including ISO 9001, ISO 13485, AS910...Full timeKingfisher Recruiting
Newark, CA5 days ago$120k - $140k
...at the forefront of safety, quality, and innovation.Our goal is... ...to industrial control systems. Solar & Commercial: Quality... ...seeking a highly motivated Test Engineer / Compliance Engineer with 2-5 years of... ...in product safety, regulatory compliance, and certification...Work experience placement- ...products. Job Summary The Quality Assurance (QA) Engineer is responsible for all... ...quality assurance and compliance with applicable regulatory requirements. The... ...processing of Complaints and CAPAs. Act as SME for the... ...multi-functional teams / system owners to lead and/or support...Work at officeLocal area
$98.08k - $127.38k
...Job Description Summary The Test Engineer is a key support role in the Engineering... ...Arbin and Neware). Documentation and quality systems: Create data summary reports, inspection... ...Corrective Actions and Preventive Actions (CAPA), and Engineering Change Orders (ECO) under...RelocationAmprius Technologies, Inc.
Fremont, CA9 days ago- Horan Hiring Solutions, LLC is seeking a Quality Engineering Manager in the Fremont, CA area (onsite) with a strong EMS background. The role requires... ...and a proven track record in customer-facing QA, audits, and CAPA-driven improvements. The ideal candidate will lead a quality...
- ...Job Description Job Description Description: Job Title Engineering Test Technician | Body Interior & Exterior Validation Job Category... ...team supporting the validation of Body Interior and Exterior systems. This hands-on role will execute laboratory tests, operate...For contractorsWork at officeRemote work
IMCS Group Inc
Newark, CA13 days ago $84.1k - $134.7k
...Customer Quality Engineer Join UCT and be part of the fastest... ...for ensuring compliance with manufacturing processes... ...-specific quality system requirements. Document... ...are necessary to meet regulatory, customer, and industry... ...preventive actions (CAPA) from initiation...Work experience placementWork at officeUCT Inc
Hayward, CA6 days ago- ...Senior Quality Engineer Unigen is a global technology company providing... ...documentation pertaining to quality systems and processes related to... ...audit of the company's compliance with ISO 9001, 13485, and 1... ...in compliance with regulatory and statutory requirements....
Unigen
Newark, CA5 days ago - ...build to print, precision machined components, anodizing and engineered thermal spray coatings. We provide customers leading edge support... ...JOB DUTIES: Responsible for driving the execution of quality goals and objectives. Read and interpret product drawings in accordance...Temporary workWork at officeFlexible hours
FM Industries
Fremont, CA5 days ago - ...Quality Engineer Seeking a Quality Engineer for a high growth chemical manufacturing client in the Fremont, CA area. The Quality Engineer would be responsible for maintaining the Quality Management System, meeting customer requirements, and driving continuous improvement...
Randstad
Fremont, CA5 days ago - ...software requirement, and each hazard that software controls, to a test and a result. You own that trace for software, working with systems engineering, and keep it current as the code changes. Release evidence — For each release: what changed, which versions, which tests...3 days per week
queueinc
Newark, CA4 days ago - ...Requirements Education: B.A. / B.S., Engineering or equivalent experience in related field... ...1-3 years of professional experience in quality engineering. · 1-3 years of mechanical... ...environment · Knowledge of various quality system methodologies (i.e. Lean, 6-Sigma,...
40HRS
Fremont, CA1 day ago $83k - $95k
...Reports To: Quality Manager Pay Range: $83,000 - $95,000/year Job Location: Vishay Applied... ...reviews of customer documentation for compliance with stated requirements, including... ...assurance activities Work closely with Process Engineering in analyzing data to evaluate the...Permanent employmentWork at officeWeekend workVishay Israel
Fremont, CA1 day ago$145k - $180k
...potential to improve the quality of life for... ...scientific, engineering, and clinical standards... ...13485 quality systems and qualification... ..., manufacturing, regulatory, and clinical affairs... ...systems and compliance activities. To Make... ...handling CAPA management Proficient...Work experience placementWork at officeLocal areaRelocationFlexible hoursNight shiftPulse Biosciences, Inc.
Hayward, CA2 days ago- 5 to 6 years of Medical Device Supplier Quality experience with Electrical background. Candidates... ...Process Validation - IQ, OQ, PQ Experience in handling SCAR, RCA, CAPA. Experience in document revision control/release process thru PLM systems #J-18808-Ljbffr Katalyst CROOverseas
- ...configuration, setup, and qualification of test systems for silicon photonic ICs, including... ...'s degree or higher in Electrical Engineering, Optical Engineering, Physics, or a... ...required PPE is available, and will monitor compliance. Quality and Environmental Responsibilities...Work at office
Coherent
Fremont, CA1 day ago $50 - $85 per hour
...- Final Onsite Interview We’re looking for an experienced engineer to support system-level testing, troubleshooting, and certification efforts... ...internal teams and suppliers Support certification and safety compliance What We’re Looking For B.S./M.S. in Aerospace, Mechanical,...Hourly payLocal areaAkkodis
Fremont, CA2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Systems Engineer: CAPA & Regulatory Compliance. Be the first to apply!
Related searches
- supplier quality engineer Fremont, CA
- quality engineer Fremont, CA
- advanced quality engineer Fremont, CA
- program quality engineer Fremont, CA
- quality systems engineer Fremont, CA
- senior manager quality engineering Fremont, CA
- customer quality engineer Fremont, CA
- quality assurance quality control engineer Fremont, CA
- quality management nurse Fremont, CA
- quality tech Fremont, CA