Quality Engineer II or Senior Quality Engineer - San Carlos - Cambridge Recruiters

    Cambridge Recruiters
    Cambridge Recruiters San Carlos

    2 days ago

    Description

    Quality Engineer II or Senior QE (Operations Quality) - title flexible based on experience

    Full-Time Permanent position, full benefits, competitive base salary, annual bonus + stock options

    Location: San Carlos, CA (on-site position)

    Company Info: 10-Person medical device startup. Round B financing recently closed.

    Product: Catheter-deployed Nitinol Implant with electronic sensors for heart failure diagnostics applications. Device is still in development-phase and expecting to have FIH by end of 2026.

    Since this is a startup, need a very hands-on person that can wear many hats and be flexible with changing priorities and fast-paced environment.

    Roles and Responsibilities

    • Provides Quality Assurance support throughout production to ensure compliance to internal and external requirements and standards (ISO 13485).
    • Manages supplier quality including performing supplier qualifications. Also as needed, along with technical team, works with key suppliers to ensure compliance to product quality requirements and lead the resolution of product quality issues
    • Manages incoming parts inspections to ensure components meet product specifications
    • Supports resolve product non conformances by supporting NCMR generation and any associated root cause analyses and CAPAs
    • Supports equipment controls including equipment installation qualifications (IQ),
    • Works with sterilization vendor to outline device sterilization procedures and manages sterilization lot release activities
    • Support company goals and objectives, policies and procedures that are related to the Quality Management System and Quality System Regulations
  • Required Qualifications

    • Bachelor's degree in Engineering or related science field required
    • MUST HAVE: Medical Device Experience
    • 3-5+ years of Operations quality assurance experience within an FDA regulated environment
    • Experience in medical device manufacturing environment with a strong working knowledge of QSR/cGMP, ISO 13485 and ISO 14971
    • Must be team oriented and have excellent communication and interpersonal skills
    • Self-directed problem solver with ability to balance independent work and collaborative cross-functional initiatives
    • Strong documentation practices
    • Prior role in an early-stage medical device company or start-up environment preferred

    Local Candidates only

    Preference given to candidates with US Work Authorization or US Citizen, however may consider a H1B Transfer for well-qualified applicants.


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