Post Market Surveillance - Quality Engineer

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 compliancewith global regulatoryrequirements and internalquality standards. Thisrole leads or facilitates complaintinvestigations, failureanalysis, adverse eventevaluations, and post-market trending activitieswhile collaborating withcross-functional teamsto identify productand 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 appliesquality engineering principles, risk management, andstatistical analysis todrive corrective andpreventive actions (CAPA), and enhance productreliability, patient safety, and continuous improvement.

Key Responsibilities

• Lead technical investigationsof customer complaints, product failures, andadverse events todetermine root cause.
• Perform trend analysisusing complaint and service datato identify emergingquality issues.
• Apply statistical methodsand quality engineeringtools to evaluateproduct performance andsupport 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 managementactivities, including updatesto risk assessments(ISO14971) based onpost-market surveillancedata.
• Collaborate with crossfunctional 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, andquality reports formanagement 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.

Qualifications

• 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 crossfunctional collaboration skills
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  Excellent technical writing, communication, andcross-functional collaborationskills

  
  
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  Experience with medicaldevice complaint handlingsystems (preferred)