Post Market Surveillance Quality Engineer

Our client is a leading innovator in medical device technology, specializing in advanced laser-powered solutions that enhance patient care. With a commitment to cutting-edge innovation and excellence, they push the boundaries of medical advancements to improve healthcare outcomes. Join a company where innovation meets purpose and help shape the future of medical technology.

The Post Market Surveillance Quality Engineer monitors the performance, safety, and quality of our client's medical devices throughout the post‑market lifecycle. This role leads complaint investigations, failure analysis, adverse event evaluations, and post‑market trending, working directly with customers to gather accurate complaint information and applying quality engineering, risk management, and statistical analysis to drive CAPA and continuous improvement.

• Lead technical investigations of customer complaints, product failures, and adverse events to determine root cause.
• Perform trend analysis using complaint and service data to identify emerging quality issues.
• Apply statistical methods and quality engineering tools to evaluate product performance and support decision-making.
• Monitor and evaluate the performance of medical devices in post‑market settings to ensure compliance with applicable regulatory requirements and to maintain high levels of safety and quality.
• Work directly with customers to obtain complete and accurate complaint information and to support failure analysis activities.
• Conduct thorough and timely investigations of adverse events and complaints related to medical devices.
• Support risk management activities, including updates to risk assessments (ISO 14971) based on post‑market surveillance data.
• Collaborate with cross‑functional teams to gather and analyze data, identify trends, and support the implementation of corrective and preventive actions (CAPA).
• Develop, maintain, and continuously improve post‑market surveillance procedures and processes to ensure compliance with regulatory standards.
• Maintain accurate, detailed, and audit‑ready records of post‑market surveillance activities, analyses, and findings.
• Communicate with regulatory agencies and respond to inquiries or requests related to post‑market surveillance activities.
• Participate in internal and external audits and inspections to demonstrate compliance with regulatory requirements.
• Stay current on industry regulations, standards, and best practices for post‑market surveillance, and communicate relevant updates to internal teams.
• Provide guidance and support to internal stakeholders on post‑market surveillance requirements, processes, and regulatory expectations.
• Develop metrics, dashboards, and quality reports for management review. Identify opportunities for improvement and drive continuous improvement initiatives to enhance product safety, quality, and performance.
• Act as a subject matter expert on post‑market surveillance, regulatory, and compliance. Promote a culture of patient safety, quality, and continuous improvement across the organization.

• Bachelor's degree in engineering or related field required.
• Minimum of 3years of experience in complaint handling/post‑market surveillance within the medical device industry.
• Familiarity with MDR filing processes and requirements for the FDA as per 21
  
  CFR
  820 and 21
  
  CFR
  803, etc.
• Strong knowledge of medical device regulations and post‑market surveillance requirements.
• Knowledge of ISO 13485 and ISO 14971 is a plus.
• Demonstrated attention to detail and ability to manage complex documentation in a regulated environment.
• Strong analytical, communication, and cross‑functional collaboration skills.
• Excellent technical writing, communication, and cross‑functional collaboration skills.
• Experience with medical device complaint handling systems (preferred).