Product Quality Engineer – Post Market Surveillance

Job Summary The Product Quality Engineer will provide quality engineering support for on-market medical devices, focusing on complaint investigations, root cause analysis, risk assessments, and post-market quality activities. This role is responsible for evaluating product complaints and field feedback, leading investigations, identifying corrective actions, and partnering with cross-functional teams to implement product and process improvements. The position plays a key role in ensuring regulatory compliance, product quality, and continuous improvement across post-market quality systems. Key Responsibilities Lead complaint investigations, root cause analysis, and risk assessments for post-market medical device issues. Prioritize complaint investigations based on product risk, trending data, and business impact. Coordinate cross-functional collaboration with Quality, Engineering, Operations, R&D, Manufacturing, and Regulatory teams. Conduct Health Risk Assessments (HRA) and evaluate field issues to determine product impact and required actions. Identify and implement corrective actions, CAPAs, and product or process improvements based on investigation findings. Perform complaint trending, failure analysis, and data analysis to identify recurring issues and risk thresholds. Present investigation findings, quality metrics, root causes, and recommendations to leadership and stakeholders. Lead implementation of design or process changes including change control documentation, testing activities, fixture/tooling updates, and drawing revisions as applicable. Develop and improve testing methods used for complaint investigations and failure analysis activities. Assess product changes for design, quality, and risk management impact. Provide post-market quality feedback to Engineering, Operations, Manufacturing, and R&D teams to improve product performance and reliability. Support complaint intake teams with technical guidance and complex investigations. Participate in field investigations and customer site evaluations alongside service and field-based teams when required. Support internal and external audits, supplier audits, FDA inspections, and Notified Body audits. Support Quality Investigation Review Boards and prepare investigation summaries, reports, and presentations. Required Qualifications Bachelor’s degree in Mechanical, Biomedical, Biomechanical, Electrical Engineering, or related engineering discipline. 5+ years of experience with a Bachelor’s degree OR 1–3 years with a Master’s degree OR 0–1 years with a PhD. Experience within FDA-regulated industries, preferably medical devices. Strong experience with complaint investigations, root cause analysis, CAPA, and post-market quality activities. Working knowledge of FDA Quality System Regulations, Design Controls, ISO 13485, EU MDR, GMP, GDP, and risk management principles. Strong understanding of root cause analysis methodologies and quality investigation tools. Excellent communication, technical writing, presentation, and cross-functional collaboration skills. Ability to work independently with minimal oversight in fast-paced, regulated environments. Preferred Qualifications Experience in product development, R&D, or design engineering. Familiarity with test method validation, statistical analysis, DOE, and reliability testing. Experience with verification & validation (V&V) activities for regulated products. Familiarity with sterilization, packaging, electrical safety, biocompatibility, and reliability standards. Experience with risk-based analysis and statistical evaluation methods. Knowledge of requirements analysis and development of measurable product specifications. Preferred Skills & Attributes Strong analytical and problem-solving skills. Ability to manage multiple investigations and priorities simultaneously. Detail-oriented with strong documentation and compliance focus. Proactive mindset with strong ownership and accountability. Ability to lead critical quality investigations and drive resolution activities effectively