Location: Marlborough, MA
Salary: $100,000.00 USD Annually - $120,000.00 USD Annually
Description: Our client is currently seeking a
Post-Market Surveillance Quality Engineer to support the ongoing monitoring, safety, quality, and performance of medical devices throughout their post-market lifecycle. This role is responsible for leading complaint investigations, conducting failure analysis, evaluating adverse events, and supporting regulatory compliance activities. The ideal candidate will leverage quality engineering principles, risk management practices, and data-driven analysis to improve product reliability, patient safety, and overall product performance.
This job will have the following responsibilities:- Lead technical investigations of customer complaints, product failures, and adverse events to determine root cause.
- Conduct complaint trend analysis and monitor post-market data to identify emerging quality and safety concerns.
- Apply statistical and quality engineering tools to evaluate product performance and support decision-making.
- Work directly with customers to collect accurate and complete complaint information.
- Support failure analysis activities and adverse event investigations.
Qualifications & Requirements:- Bachelor's degree in Engineering, Quality, Biomedical Engineering, Life Sciences, or a related field.
- 3-5 years of post-market surveillance, complaint handling, quality engineering, or medical device quality experience.
- Strong understanding of medical device regulations and post-market surveillance requirements.
- Experience conducting complaint investigations, failure analysis, and CAPA activities.
- Knowledge of risk management methodologies, including ISO 14971.
- Strong analytical, problem-solving, and data analysis skills.
- Medical device manufacturing or regulated healthcare industry experience.
- Experience supporting regulatory inspections and audits.
- Familiarity with quality management systems and continuous improvement methodologies.
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