Principal Quality Engineer

Job Title

Principal Quality Engineer – Contract-to-Hire (Medical Device)

$65.00/hr – $85.00/hr

We are seeking a dynamic and experienced Principal Quality Engineer to lead quality engineering initiatives ensuring ongoing safety, efficacy, and compliance of medical devices as they enter the market. This is a contract-to-hire position.

• Lead the development and implementation of quality systems in compliance with FDA and ISO 13485 regulations.
• Analyze and manage Corrective and Preventive Actions (CAPA) to ensure effective resolution of quality issues.
• Utilize problem‑solving methodologies such as Fishbone or DMAIC to identify root causes and implement corrective actions.
• Maintain the FDA QMSR and ensure all quality metrics are met or exceeded.
• Provide consultation to various departments on quality systems, regulatory compliance, and risk management.
• Conduct internal and external audits to ensure compliance with regulatory standards.
• Lead and oversee post‑market surveillance programs.
• Collaborate with cross‑functional teams to drive continuous improvement initiatives.
• Lead the review and approval of design and process changes, ensuring compliance with quality standards and regulatory requirements.

• Bachelor's degree in Engineering, Quality Assurance, or a related field.
• Minimum 12 years of experience in a quality engineering role with strong medical device industry experience.
• Extensive knowledge of FDA regulations, ISO 13485, Fishbone, DMAIC, 8D, and/or FDA QMSR.
• Expertise in post‑market quality system activities including complaint handling, vigilance/adverse event reporting, HHE, and post‑market surveillance.
• Experience conducting and leading complex investigations and implementing CAPA.
• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) is preferred.

• Company equity.
• Excellent medical, dental, and vision package.
• 401(k) with match.
• Generous PTO.
• Opportunity to make a difference in people’s lives.

Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories.

It is Jobot’s policy to comply with all applicable federal, state, and local laws respecting consideration of unemployment status in making hiring decisions.

Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

Information collected and processed as part of your job application is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners.