Job SummaryThe Post Market Surveillance Quality Engineer is responsible for monitoring the performance, safety, and quality of IPG Medical devices throughout the post-market lifecycle to ensure compliance with global regulatory requirements and internal quality standards. This role leads or facilitates complaint investigations, failure analysis, adverse event evaluations, and post-market trending activities while collaborating with cross-functional teams to identify product and process improvements. This role works directly with customers to gather accurate complaint information and supports failure analysis, adverse event investigations, and regulatory reporting. The engineer applies quality engineering principles, risk management, and statistical analysis to drive corrective and preventive actions (CAPA), and enhance product reliability, patient safety, 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 related to 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 the safety, quality, and performance of IPG Medical devices.
- Act as a subject matter expert on post-market surveillance regulatory compliance for IPG Medical products.
- Promote a culture of patient safety, quality, and continuous improvement across the organization.
Qualifications- Bachelor's degree in engineering or related field required
- At least 3- 5 years of experience in post-market surveillance within the medical device industry
- Strong knowledge of medical device regulations and post-market surveillance requirements
- 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)
