Quality Engineer

This range is provided by Lumicity. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

Direct message the job poster from Lumicity

Overview: The Quality Engineer will play a pivotal role in risk management, efficacy, and compliance of medical devices focusing kidney disease. This senior-level provides opportunities for technical leadership and strategic oversight of post‑market activities. The candidate will handle product quality, vigilance reporting, as well as post‑market surveillance/risk management. The Quality Engineer will serve as the expert on post‑market regulatory requirements, and partners cross‑functionally to ensure timely, effective, and compliant execution of quality system processes.

• Lead and oversee post‑market surveillance programs to monitor product performance, safety trends, and emerging risks
• 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
• Provide technical leadership for root cause analysis of customer success, field issues, and adverse event reporting
• Ensure timely evaluation of, investigation, and complaint in compliance with FDA, ISO 13485, and other global regulations
• 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

• Adept knowledge of global quality and regulatory standards, including ISO 13485, ISO 14971, and FDA QMSR.
• Expertise in post‑market quality system activities, including complaint handling, vigilance/adverse event reporting, health hazard evaluations (HHE), and post‑market surveillance.
• 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.

• Bachelor’s degree in Engineering, Life Sciences, or related field (advanced degree preferred).
• 15+ years of progressive quality engineering experience in the medical device industry, with demonstrated expertise in design, manufacturing, and post‑market quality systems.
• Strong knowledge of FDA Quality System Regulation, ISO 13485, and other relevant standards.
• Proven success in complaint handling, risk management, and CAPA execution.
• Experience with complex electromechanical devices preferred.

• Use of personal protective equipment (PPE) may be required.

Mid‑Senior level

Full‑time

Quality Assurance and Engineering

Medical Equipment Manufacturing