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.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).
- Minimum 10 years of experience in medical device quality engineering, with at least 5 years in post-market quality.
- In-depth knowledge of Class III medical devices and associated regulatory requirements (FDA 21 CFR Part 820, ISO 13485, EU MDR).
- Proven experience with complaint handling systems, CAPA, and risk management (ISO 14971).
- Strong analytical, problem-solving, and communication skills.
- Experience with quality management systems (QMS) and electronic systems (e.g., TrackWise, MasterControl).
Preferred Skills:
- RAC or ASQ certifications.
- Experience with implantable or life-sustaining devices.
- Familiarity with global regulatory environments
FAQs
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