Principal Quality Engineer

Medical Device Leader! Principal Quality Engineer Opportunity!

We are a leading medical device company focused on improving care and quality of life for patients with kidney disease. The role is a CONTRACT-TO-HIRE position, offering a salary of $65–$85 per hour.

• 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 Quality Management System Reporting (QMSR) and ensure that 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 of 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 a 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, disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment based on any of these protected categories.

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