Quality Engineer: ISO 9001/13485 CAPA & Audit Lead
$95k - $115kApplied Industrial Technologies
Applied Industrial Technologies is seeking a Quality Engineer for their Newark, CA location. The role involves managing product quality and supporting the Quality Management System (QMS) for ISO 9001 and ISO 13485. Candidates should have a B.S. in Mechanical, Electrical, or Materials Engineering, along with 2-5 years of relevant experience. The estimated total compensation ranges from $95,000 to $115,000, based on experience, along with typical benefits. #J-18808-Ljbffr Applied Industrial Technologies
$95k - $115k
Bay Advanced Technologies, LLC in Newark, CA is seeking a Quality Engineer to support ISO9001/ISO13485 QMS practices. This role involves performing audits, resolving product quality issues, and collaborating with suppliers. The ideal candidate will have a BS in Engineering...Suggested- ...Manufacturing Fremont is seeking a Corporate Quality Engineer to lead quality system activities and ensure adherence to ISO 9001 standards across operations. The role focuses on CAPA investigations, document control, audits, and ongoing QMS governance. The incumbent will...Suggested
- Unigen Corporation is looking for a Senior Quality Engineer in Newark, CA. The role involves... ...quality control experience, and knowledge of ISO standards. Interested applicants should... ...Six Sigma and have experience conducting audits and inspections. Excellent problem-solving...Suggested
$95k - $115k
...is currently looking for a Quality Engineer to join our team in Newark,... ...quality issues, internal/external audits and documentation... ...preventive actions to complete 8D CAPA reporting to customers and enhance... ...independently. Knowledge of ISO 9001/13485 Quality Management Systems...SuggestedHourly payFull timeWork experience placement- ...Quality Engineering Manager Unigen, headquartered in Newark... ..., we've grown into a leading provider of electronics... .... Manage customer audits, quality reviews, and... ...systems, including ISO 9001, ISO 13485, AS9100, and IATF 16... ...and Preventive Action (CAPA) programs and ensure...SuggestedFull time
- ...Site | Reports To: Quality Manager About... ...Supplier Quality Engineer (SQE) is a key member... ...suppliers through on‑site audits, capability... ...and manage SCARs/CAPAs to timely resolution... ...actions. Maintain ISO 9001 compliance and support... ...the supply base. Lead supplier‑facing CI...Full time
- ...energy, technically minded Junior Quality Engineer to join our quality team. This... ...production floor. Root‑Cause & CAPA Support: Assist engineering teams... ...forms to ensure alignment with ISO 9001 and ISO 13485 standards. Equipment & Audits: Assist with the calibration of...Contract workInternship
- ...Job Title Senior Quality Engineer Location Newark, CA Department Quality... ...as found during the internal audit. Conduct root cause analysis... ...methods for customer products. Lead the internal audit team by... ...company’s compliance with ISO 9001, 13485, and 14001 and QMS standards...
$80k - $110k
...As the Quality Engineer, you will be responsible for ensuring... ...production of industry-leading technology solutions.... ...and preventive actions (CAPA) using structured... ...and support internal audits, process audits, and compliance... ...compliance with ISO 9001 and other applicable...Contract workTemporary workFlexible hours- ...subsidiary Bay Advanced Technologies, is hiring a Quality Engineer in Newark, CA. This position focuses on quality assurance tasks including audits and document control while welcoming... ...of relevant experience, particularly in ISO management systems. The role offers a competitive...
- Position Summary The RMA Quality Engineer is responsible for managing and improving... ...& Preventive Actions (CAPA) Drive corrective actions... ...Participate in customer calls and audits when required Analyze RMA... ...compliance with quality standards (ISO 9001, IPC, etc.) Support audits...
- The Corporate Quality Engineer is responsible for executing and managing... ...system activities, including CAPA investigations, Document Control... ...management, and internal ISO 9001 audit execution. This role... ...systemic quality failures and lead the implementation of corrective...
- The Quality System Engineer is responsible for supporting the implementation... ...a primary focus on CAPA, Complaint Handling,... ...Management, audit processes, and quality... ...1 CFR Part 820/QMSR), ISO 13485, and other global standards... ...CQE, CQA, or ISO 13485 Lead Auditor certification....Work at office
- THINK Surgical is seeking a Quality System Engineer in Fremont, CA, responsible for supporting the Quality... ..., maintain procedures, and support audits. The ideal candidate has a Bachelor’s degree... ...device sector, and strong skills in CAPA and compliance. This role is crucial to...
- Early Career Talent - Quality Assurance Engineering - Immediate Start At Western Digital, our vision... ...System (QMS) in alignment with ISO 9001 and corporate requirements. Participating in internal audits , compliance checks, and CAPA tracking to drive continuous improvement...Full timeTemporary workH1bImmediate startRemote workFlexible hoursShift work
- ...Senior Manager / Associate Director of Quality Systems & Audits to lead global internal audits and coordinate... ...Director of QA and drives governance, CAPA, and continuous improvement across a highly... ...0 years in QA within FDA-regulated or ISO-certified labs or medical devices,...
- ...is passionate about quality craftsmanship.... ...Quality Assurance Engineer (Manufacturing) supports... ...process variation and lead improvement efforts... ...management, and CAPA. Conduct internal audits and support customer... ...concepts including ISO 9001 and/or ISO 13485. ~ Proficiency...Monday to FridayShift work
$130k - $155k
Sr. Software Quality & Compliance Engineer Fremont, CA Personalis, Inc.... ...this role, you will lead Computer System Validation... ...CFR Part 11 and 820, ISO 13485, IEC 62304, etc.),... ...IT to maintain an audit-ready posture against... ...as Document Control, CAPA, and Change Management...Full time$130k - $155k
...on clinical accuracy, quality, big data, scale and efficiency... ...Quality & Compliance Engineer to serve as the vital... ...1 CFR Part 11 and 820, ISO 13485, and IEC 62304) and... ...maintain a proactive, audit‑ready posture against emerging... ...as Document Control, CAPA, and Change Management....Full time- FCX Performance is looking for a Quality Engineer in Newark, CA. This position requires a BS in Engineering... ...root cause analyses, supplier audits, and supporting QMS document updates. The... ...communication skills and a knowledge of ISO standards. #J-18808-Ljbffr FCX...
$110k - $140k
...Job Purpose The Senior Quality Engineer is responsible for supporting all... ...sustaining changes. This includes auditing, verifying, validating... ...are implemented. Incorporate ISO, API Q1, and AS9100 standards... ...ISO requirements. Support the CAPA program to facilitate timely...Permanent employment$100k - $130k
...meticulous and hands-on Quality Engineer to bolster our Manufacturing... .../preventive actions (CAPA) to mitigate quality... ...Contribute to internal audits and uphold compliance with ISO 9001 and client-specific standards... ...us apart. We continue leading global talent solutions...Full timeWork experience placementWork at officeRemote work- ...design, production and quality control processes... ...with internal engineers and consultants (technical... ...and executing audits to ensure... ...requirements are be met. Lead SCAR activities... ...ensuring all facets of CAPA activities are... ...Internal audits to ISO 9001, IATF 16949, ISO...
$75k - $95k
...and ambitious person to fill a Quality Engineer position. In this role, you... ...quality concerns. Nature Of Duties Lead corrective action teams and... ...and report on internal audits. Participate in engineering CCB... ...industry quality standards, e.g. ISO 9001, AS 9100, TL 9000, NADCAP....Permanent employmentFull time- ...We have a variety of Quality Engineering openings, including RMA Quality Engineer, Supplier Quality... ...knowledge of quality standards – ISO 9001, Six Sigma, Lean Manufacturing, Certification... .... Conduct risk assessments and process audits to identify potential quality issues...Overseas
$81.5k - $141.3k
...spectrum of healthcare, with leading businesses and products in... ...than 160 countries. 2nd shift Quality Engineer II Working at Abbott At... ...business unit model preferred. CAPA owner or key cross-functional... ...Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971. Risk...Work experience placementAfternoon shift- ...and detail-oriented sr. Quality Engineer to join our dynamic... ...processes, conducting audits, and collaborating with... ...Conduct regular audits (ISO, internal, and customer... ...Cybersecurity Management, and 8D CAPA reports, AS9102 reports... ...with ISO lead auditor and/or ASQ CQE...
$90k - $115k
...national defense. Join our Quality Assurance team in Palo... ...a Quality Assurance Engineer, you’ll be at the... ...production data, conduct audits and inspections, and... ...production teams, and project leads to troubleshoot... ...practices Experience with ISO 9001, ISO 13485, FDA QAR, AS9100, or...Permanent employmentWork at officeImmediate start- ...We are seeking a Supplier Quality Engineer (SQE) to manage and improve the quality of products... ...will also play a key role in supplier audits, problem‑solving, and ensuring compliance... ...Knowledge of quality systems, standards (e.g., ISO 9001, Six Sigma), and best practices....
- ...40 hours, M - F day shift Position: Quality Engineer Location: San Jose, CA Duration: 6... ...(i.e.: Good Manufacturing Practices, ISO, FDA). Proven ability to develop solutions... ...based results and decisions. ISO 9001/13485 lead auditing experience. Strong Troubleshooting...Contract workDay shift
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