Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Regulatory Quality Engineer — Audit Readiness & CAPA Lead in Santa Clara, CA vacancy
  •  .... 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... 
    Regulatory
    Work at office
    Local area
    Worldwide

    Intuitive

    Sunnyvale, CA
    3 days ago
  • 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,... 
    Regulatory
    Contract work

    EBR Systems, Inc.

    Sunnyvale, CA
    4 days ago
  • 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

    Spectraforce Technologies

    Santa Clara, CA
    2 days ago
  • 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... 
    Regulatory
    Contract work

    Actalent

    Santa Clara, CA
    4 days ago
  •  ...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... 
    Regulatory
    Hourly pay
    Full time
    Temporary work
    Internship
    Local area
    Flexible hours

    Align Technology

    San Jose, CA
    7 days ago
  • $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... 
    Regulatory
    Relocation

    Apple Inc.

    Cupertino, CA
    4 days ago
  • $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... 
    Regulatory
    Work at office

    Foxconn Industrial Internet - FII

    San Jose, CA
    4 days ago
  •  ...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

    Katalyst HealthCares & Life Sciences

    Santa Clara, CA
    3 days ago
  • $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... 
    Regulatory
    Full time
    Contract work
    Temporary work
    Work at office

    Actalent

    Santa Clara, CA
    3 days ago
  •  ...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,... 
    Regulatory
    Work at office
    Local area
    Worldwide

    Intuitive

    Sunnyvale, CA
    2 days ago
  •  ...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,... 
    Regulatory
    Local area

    Spherion Staffing Corporation

    San Jose, CA
    19 days ago
  • $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... 
    Regulatory
    Full time
    Local area
    Work visa

    Cordis

    Santa Clara, CA
    1 day ago
  • $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... 
    Regulatory
    Full time
    Temporary work
    Local area
    Flexible hours

    Stryker

    San Jose, CA
    6 days ago
  • $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... 
    Regulatory
    Temporary work
    Flexible hours

    Oracle

    Santa Clara, CA
    1 day ago
  • $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... 
    Regulatory
    Contract work
    Flexible hours

    EBR Systems, Inc.

    Sunnyvale, CA
    1 day ago
  •  ...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... 
    Regulatory
    Work experience placement
    Work at office

    Intuit

    Mountain View, CA
    2 days ago
  • $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... 
    Regulatory
    Contract work
    Temporary work
    Work at office
    Immediate start

    Actalent

    Santa Clara, CA
    4 days ago
  • $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... 
    Regulatory
    Permanent employment
    Full time
    Work at office
    Immediate start

    Cirexx International, Inc.

    Santa Clara, CA
    4 days ago
  • $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

    Apple Inc.

    Cupertino, CA
    4 days ago
  • $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... 
    Regulatory
    Full time
    Work at office

    Olympus

    San Jose, CA
    5 days ago
  • $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... 
    Regulatory
    Local area

    Archer56

    San Jose, CA
    4 days ago
  • $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

    Halo Industries

    Santa Clara, CA
    2 days ago
  • $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... 
    Regulatory
    Local area

    Archer

    San Jose, CA
    4 days ago
  • $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... 
    Regulatory
    Full time
    Temporary work
    Summer holiday
    Worldwide
    Flexible hours

    Picarro

    Santa Clara, CA
    4 days ago
  •  ...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... 
    Regulatory
    Contract work
    Work at office
    Local area

    Ultimate Staffing

    Milpitas, CA
    2 days ago
  • 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... 
    Regulatory
    Full time
    Work experience placement
    Local area
    Worldwide
    Shift work

    Intuitive

    Sunnyvale, CA
    3 days ago
  • 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... 
    Regulatory
    Full time
    Local area
    Worldwide
    Flexible hours
    Shift work

    Intuitive

    Sunnyvale, CA
    3 days ago
  • $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... 
    Regulatory
    Full time
    Work at office
    Local area
    Shift work
    Day shift

    Foxconn Industrial Internet - FII

    San Jose, CA
    a month ago
  • $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... 
    Regulatory
    Full time
    Contract work
    For contractors
    For subcontractor
    Casual work
    Work at office
    Remote work
    Day shift

    Decisive Point

    Sunnyvale, CA
    2 days ago
  • 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... 

    Cirexx International, Inc.

    Santa Clara, CA
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Regulatory Quality Engineer — Audit Readiness & CAPA Lead. Be the first to apply!