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.
Position: 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.
Key Responsibilities:
- 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.
Requirements:
- Bachelor’s degree in engineering or related field required.
- Minimum of 3 years 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 21CFR820 and 21CFR803, 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).
