Post Market Surveillance - Quality Engineer - Marlborough, MA

Job Summary

The Post Market Surveillance Quality Engineer is responsible for monitoring the performance, safety, and quality of IPG Medical devices throughout thepost-market lifecycleto ensure compliance with global regulatory requirements and internal quality standards. Thisrole leads or facilitates complaint investigations, failure analysis, adverse event evaluations, and post-market trending activities while collaborating withcross-functional teamsto 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 todrive corrective and preventive actions (CAPA), and enhance product reliability, patient safety, 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 datato identify emerging quality issues.
• Apply statistical methods and quality engineeringtools to evaluate product performance and support decision-making.
• Monitor and evaluate the performance of medical devices in postmarket 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 updatesto risk assessments(ISO
  14971) based onpost-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 postmarket surveillance procedures and processes to ensure compliance with regulatory standards.
• Maintain accurate, detailed, and auditready records of postmarket surveillance activities, analyses, and findings.
• Communicate with regulatory agencies and respond to inquiries or requests related to postmarket 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 postmarket surveillance and communicate relevant updates to internal teams.
• Provide guidance and support to internal stakeholders on postmarket 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 postmarket surveillance regulatory compliance for IPG Medical products.
• Promote a culture of patient safety, quality, and continuous improvement across the organization.

• Bachelor's degree in engineering or related field required
• At least 3- 5 years of experience in postmarket surveillance within the medical device industry
• Strong knowledge of medical device regulations and postmarket 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, andcross-functional collaboration skills
• Experience with medical device complaint handlingsystems (preferred)