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Principal Quality Engineer

3 weeks ago

Irvine, California, United States Real Full time

The Principal Quality Engineer will play a critical role in ensuring the ongoing safety, efficacy, and compliance of our medical devices after they have entered the market. This senior-level role provides technical leadership and strategic oversight of post-market quality activities, including complaint handling, vigilance reporting, post-market surveillance, risk management, and continuous product improvement. The Principal Quality Engineer serves as a subject matter expert (SME) on post-market regulatory requirements and partners cross-functionally to ensure timely, effective, and compliant execution of quality system processes.

Responsibilities

  • Lead and oversee post-market surveillance programs to monitor product performance, safety trends, and emerging risks.
  • Provide technical leadership for root cause analysis of customer complaints, field issues, and adverse events.
  • Ensure timely evaluation, investigation, and closure of complaints in compliance with FDA, ISO 13485, and other global regulations.
  • Collaborate with R&D, Manufacturing, and Service teams to drive effective corrective and preventive actions (CAPA).
  • Partner with regulatory affairs to manage global adverse event reporting requirements.
  • Collaborate with Clinical, Regulatory, and Field Service teams to strengthen the post-market surveillance.
  • Support supplier quality, process validation, and production controls to ensure consistent compliance with ISO 13485 and FDA QSR requirements.

Required Skills & Abilities

  • Experience working with
    complex electromechanical software medical devices
  • Expertise in post-market quality system activities
    , including complaint handling, vigilance/adverse event reporting, health hazard evaluations (HHE), and post-market surveillance.
  • Hands on, technical expertise
    within the quality engineering space, taking ownership of complaint investigations
  • Deep knowledge of global quality and regulatory standards, including ISO 13485, ISO 14971, and FDA QMSR.Demonstrated ability to conduct and lead complex investigations and implement effective corrective and preventive actions (CAPA).
  • Skilled in structured problem-solving techniques such as (i.e. 8D, Fishbone, DMAIC, etc.).
  • Strong command of statistical methods (DOE, regression, sampling plans, capability analysis).
  • Collaborative mindset with the ability to build partnerships across R&D, Regulatory, Operations, and Clinical teams.
  • Effective verbal and written communication skills.

EOE Statement:
Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

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