Principal Post Market Quality Engineer

Position Summary:

We are seeking a highly experienced and strategic Principal Quality Engineer to lead post-market quality activities for our Class III medical devices. This role is critical in ensuring the continued safety, performance, and regulatory compliance of our products once they are in the market. The ideal candidate will have deep expertise in complaint handling, adverse event reporting, field actions, and post-market surveillance, with a strong understanding of global regulatory requirements.

Key Responsibilities:

• Post-Market Surveillance:

  • Lead the development and execution of post-market surveillance plans in accordance with FDA, EU MDR, and other global regulatory requirements.
  • Analyze product performance data and trends to identify potential safety or quality issues.

• Complaint Handling:

  • Oversee the complaint management process, ensuring timely investigation, root cause analysis, and closure.
  • Collaborate with cross-functional teams to implement corrective and preventive actions (CAPA).

• Adverse Event Reporting:

  • Ensure timely and accurate reporting of adverse events to regulatory bodies (e.g., FDA, EMA).
  • Maintain compliance with vigilance reporting requirements globally.

• Field Actions:

  • Lead risk assessments and decision-making processes for field actions including recalls and notifications.
  • Coordinate with regulatory affairs and operations to execute field actions effectively.

• Continuous Improvement:

  • Drive improvements in post-market quality systems and processes.
  • Mentor junior engineers and provide technical leadership across quality functions.

• Regulatory Compliance:

  • Stay current with evolving global regulations and standards related to post-market activities.
  • Support audits and inspections by regulatory agencies and notified bodies.