Principal Post-Market Quality Engineer - Medical Devices

Cordis; Irvine (CA); On-site; USD 115,000 - 165,000; Full time

Job summary

Cordis seeks a Principal Sustaining Quality Engineer (Post-Market) to ensure medical devices remain compliant and safe after commercialization. You will drive post-market plans, lead investigations into adverse events, and manage datasets to identify trends and emerging risks.

Key responsibilities include maintaining PMS metrics, supporting product recalls and safety notices, and coordinating audits with cross-functional teams.

Qualifications

• 8+ years of experience in medical device, pharmaceutical, and combination-product industries with significant PMS, complaint handling, vigilance, adverse event reporting, and quality systems experience.
• Experience with implantable, interventional, catheter-based, drug-device combination, or cardiovascular products preferred.

Responsibilities

• Develop, maintain, and execute post-market plans, procedures, and reporting activities to ensure regulatory compliance.
• Lead or support investigations into product complaints, nonconformities, and field performance issues; identify trends and risks.
• Establish post-market metrics, dashboards, and management-review inputs.
• Support field actions, recalls, safety notices, and customer communications as needed.
• Participate in internal, supplier, and regulatory audits and respond to audit observations.
• Maintain awareness of applicable regulations and industry guidance.

Skills

Post-Market Surveillance

Complaint handling

Vigilance

Statistical analysis

Technical writing

Problem solving

Data interpretation

English fluency

Education

Bachelor's degree in Biomedical Engineering or Mechanical Engineering

Job description

Cordis seeks a Principal Sustaining Quality Engineer (Post-Market) to ensure medical devices remain compliant and safe after commercialization. You will drive post-market plans, lead investigations into adverse events, and manage datasets to identify trends and emerging risks.

Key responsibilities include maintaining PMS metrics, supporting product recalls and safety notices, and coordinating audits with cross-functional teams.