Regulatory Quality Engineer — Audit Readiness & CAPA Lead
Spectraforce Technologies Inc
Spectraforce Technologies is seeking a Regulatory Quality Engineer in Santa Clara, CA for a 12-month assignment. This role provides quality system and compliance support to the Regulatory Affairs organization, focusing on KPI dashboards, audit preparedness, CAPA handling, and cross-functional quality improvements. The ideal candidate will have experience with medical device US and CE regulations, drive risk mitigation, and support post-approval commitments while advancing QMS initiatives within #J-18808-Ljbffr Spectraforce Technologies
- .... We’re a team of engineers, clinicians, and innovators... ...a life. If you’re ready to contribute to... ...contributor leading complex QMS... ...remediation actions, audit readiness, and cross-functional quality system projects. Provides... .... Support regulatory inspections, notified...RegulatoryWork at officeLocal areaWorldwide
- EBR Systems, Inc. is seeking a Senior Quality Engineer to join cross-functional teams for product specification development... ...validations, risk analysis, and human factors. Lead CAPA and ensure compliance with QMS and regulatory requirements. You will support production,...RegulatoryContract work
- Title: Regulatory Quality Engineer Duration: 12 Months Location: Santa Clara, CA 95054 Description /... ...metrics. Managing strategic program for RA audit preparedness including anticipatory... ...Investigating non-conformances (e.g., CAPAs), implementing mitigations, and...Regulatory
- Actalent is seeking a Quality Engineer for a contract-to-hire role in Santa Clara, CA. You will independently lead complex quality investigations, drive CAPAs, and manage customer complaints in a regulated manufacturing environment. Responsibilities include applying structured...RegulatoryContract work
- ...seeking a Sr. Quality Systems professional... ...the ability to lead cross-... ...activities across CAPA, Nonconformance... ...Management, Internal Audits, Management... ...Partner with Engineering, Manufacturing, Operations, Regulatory Affairs, and Quality... ..., inspection readiness activities, and...RegulatoryHourly payFull timeTemporary workInternshipLocal areaFlexible hours
$146.3k - $244.1k
...committing to the values that lead to great work. Every new... ..., healthier lives. Be ready to make something great when... ...based internal & supplier audit program to ensure ongoing regulatory compliance and encourage continuous... ...matter expert on the quality management system audit...RegulatoryRelocation$95k - $105k
...and driven Senior Quality Engineer to join our team.... ...customers. You will lead data-driven... ..., onboarding, and audit activities, including... ...capability and production readiness. Monitor supplier... ...such as 8D, CAPA, Fishbone, and 5-Why... ...customer, supplier, and regulatory audits by ensuring...RegulatoryWork at office- ...Senior Quality Engineer We are seeking an experienced... ...Engineering and Regulatory Compliance. The... ...surveillance, CAPA, and regulatory compliance... ...include: Leading design transfer... ...manufacturing readiness and quality... ..., and regulatory audits and ensuring timely...Regulatory
$56.5 per hour
...Job Title: Senior Quality EngineerJob Description... ...Senior Quality Engineer (Quality Engineer... ...manufacturing‑ready documentation, ensuring... ...consistency, and regulatory compliance.... ...preventive actions (CAPA) by documenting root... ...consistently followed. Lead or participate in...RegulatoryFull timeContract workTemporary workWork at office- ...We’re a team of engineers, clinicians, and... ...life. If you’re ready to contribute to... ...enterprise‑level quality outcomes by leading strategic... ...investigations and audits Identify, execute... ...protocols Lead critical CAPAs Serve as subject... ...company and regulatory standards (GMP,...RegulatoryWork at officeLocal areaWorldwide
- ...Description Role Summary The Quality Engineering Technician supports and... ...documentation, support audits, and manage changes (... .... Problem Solving: Lead root cause investigations using CAPA and 8D methodologies.... ...CAD familiarity. Regulatory Knowledge: ISO 9001,...RegulatoryLocal area
$95k - $120k
...challenge and are ready to have a direct,... ...The Senior Quality Assurance Engineer is responsible for... ...Manufacturing, Engineering, Regulatory Affairs, Supply... ...Actions (CAPA) Nonconforming Material... ...Internal Audits Document Control... ...Review meetings. Lead or support medium...RegulatoryFull timeLocal areaWork visa$133.4k - $222.3k
...is hiring a Senior Staff Quality Engineer for our Endoscopy division... ...processes. Advocate and lead the execution of initiatives... ...oversight and approval of NC/CAPA, activist and high-level... ...lead internal and external audits with regulatory representatives, providing...RegulatoryFull timeTemporary workLocal areaFlexible hours$102.3k - $209.5k
Principal Supply Chain Quality Engineer The Principal... ...Excellence Lead quality initiatives... ...quality reviews, audits, corrective action... ...and operational readiness objectives. Continuous... ...Methodologies CAPA Systems Quality... ...management Regulatory and industry quality...RegulatoryTemporary workFlexible hours$115.6k - $156.4k
...Senior Manufacturing Quality Engineer will work cross... ...monitoring, and leading investigations to... ...systems and regulatory requirements. Additionally... ...internal audits, maintaining up-to... ...timely closure of CAPAs, NCRs, and complaints... ...challenge, and ready to shape the...RegulatoryContract workFlexible hours- ...reporting integrity and readiness for change. Within... ..., Operations & Audit Excellence team is... ...'re looking for a Lead, SOX Program... ...driving coverage, quality, and strategic improvement... ...the evolving regulatory environment (PCAOB... ...including technical and engineering audiences. Proven...RegulatoryWork experience placementWork at office
$56.5 per hour
...Job Title: Quality EngineerJob Description The Quality Engineer independently leads complex quality investigations... ...preventive actions (CAPAs), and customer complaints... ...product quality, regulatory compliance, and customer... ...expertise during audits, regulatory inspections...RegulatoryContract workTemporary workWork at officeImmediate start$93.6k - $104k
Now Hiring: Quality Systems/Quality Assurance Engineer & Compliance Specialist Overview We... ...Management System, support audit readiness, and ensure compliance... ...customer, contractual, and regulatory requirements. This role... ...using root cause and CAPA methods. Support document...RegulatoryPermanent employmentFull timeWork at officeImmediate start$146.3k - $244.1k
A leading technology company in Cupertino is seeking a Senior Lead Auditor to... ...you will lead internal and supplier audits to ensure compliance with regulatory standards. Ideally, candidates should... ...over 5 years of experience with Quality Management Systems and relevant regulatory...Regulatory$86.47k - $116.73k
...Quality Engineer II Location: California, San Jose Job Summary The Quality... ..., projects (including CAPAs and audit responses), and engineering... ...procedures that meet customer and regulatory requirements, serve as the... ...as the site Quality lead for Supply Chain. Ensure inspections...RegulatoryFull timeWork at office$83.7k - $135.1k
...5+ years of experience in Supplier Quality or Manufacturing Engineering, with a specific focus on Powertrain... ...and system levels. Certification & Regulatory Support: Previous experience... ...: Expertise in evaluating supplier readiness and scalability for powertrain and...RegulatoryLocal area$130k - $145k
...highly motivated Sr. Customer Quality Engineer to join our quality team. In... ...qualification materials. Audits & Compliance: Schedule and host... ...approval. Manufacturing Readiness: Implement and oversee processes... ..., with a proven ability to lead cross-functional teams and...Temporary work$94k - $129.3k
..., and systems meet design, quality, safety, regulatory, and industry-specific requirements... ...Work closely with design engineers, manufacturing engineers,... ..., control plans and SPC Lead the establishment of... ...corrective/preventive actions (CAPA) Develop reports summarizing...RegulatoryLocal area$140k - $150k
...Job Title Senior Quality Engineer Job Location Santa Clara,... ...customer satisfaction, and regulatory compliance. This role... ..., including internal audits, external audit... ...nonconformance management, CAPA, 8D investigations, and... ...management review support. Lead corrective action and...RegulatoryFull timeTemporary workSummer holidayWorldwideFlexible hours- ...are seeking a Quality Management Systems (QMS) Engineer to join a client... ...This person will lead and... ...possess strong auditing, quality systems... ...compliance and readiness. Manage the Corrective... ...Preventive Action (CAPA) process,... ...with changing regulatory, customer, and...RegulatoryContract workWork at officeLocal area
- Senior Quality Engineer - Multiport Da Vinci Full‑time Shift: Day Max.... ...to change a life. If you’re ready to contribute to something... ...external design control and regulatory requirements. Essential Job... ...Support internal and external audits, including preparation and...RegulatoryFull timeWork experience placementLocal areaWorldwideShift work
- Senior Quality Engineer - Future Forward / NPD Full‑time Shift: Day Max... ...change a life. If you’re ready to contribute to something bigger... ...external design control and regulatory requirements. Roles &... ...support internal and external audits, including preparation and direct...RegulatoryFull timeLocal areaWorldwideFlexible hoursShift work
$95k - $105k
...and driven Senior Quality Engineer to join our team.... ...customers. You will lead data-driven... ..., onboarding, and audit activities, including... ...capability and production readiness. Monitor... ...methodologies such as 8D, CAPA, Fishbone, and 5-... ..., supplier, and regulatory audits by ensuring...RegulatoryFull timeWork at officeLocal areaShift workDay shift$160k - $190k
...multifaceted Risk and Compliance Lead to lead our security... ...will collaborate with legal, engineering, operations and customers, as... ...defense requirements - owning audit readiness, evidence collection, and... ...enforceable, and aligned to regulatory and contractual obligations...RegulatoryFull timeContract workFor contractorsFor subcontractorCasual workWork at officeRemote workDay shift- Cirexx International, Inc. is seeking a detail-oriented Quality Systems/Quality Assurance Engineer & Compliance Specialist to maintain and improve the QMS, support audit readiness, and ensure compliance with aerospace defense requirements. This role collaborates with Engineering...
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