Post-Market Quality Engineer: Investigations & Analysis

The Judge Group; Marlborough (MA); On-site; USD 100,000 - 120,000; Full time

Job summary

The Judge Group is seeking a Post-Market Surveillance Quality Engineer in Marlborough, MA to support monitoring, safety, quality, and performance of medical devices throughout their post-market lifecycle. You will lead complaint investigations, perform failure analysis, evaluate adverse events, and assist with regulatory compliance activities.

The ideal candidate has a bachelor's degree in engineering or life sciences and 3–5 years of post-market surveillance or medical device quality

Qualifications

• 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.

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.

Skills

Analytical thinking

Problem-solving

Data analysis

Regulatory knowledge

Education

Bachelor's degree in Engineering/Quality/Biomedical Engineering/Life Sciences

Job description

The Judge Group is seeking a Post-Market Surveillance Quality Engineer in Marlborough, MA to support monitoring, safety, quality, and performance of medical devices throughout their post-market lifecycle. You will lead complaint investigations, perform failure analysis, evaluate adverse events, and assist with regulatory compliance activities.

The ideal candidate has a bachelor's degree in engineering or life sciences and 3–5 years of post-market surveillance or medical device quality