Post-Market Quality Engineer: CAPA & Patient Safety

RadNet, Inc.; Marlborough (MA); On-site; USD 93,000 - 123,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan

Employee Stock Purchase Plan (ESPP)

Tuition Reimbursement

Employee Assistance Program (EAP)

Job summary

RadNet, Inc. is seeking a Post Market Surveillance Quality Engineer in Marlborough, MA to monitor IPG Medical devices post-market, drive CAPA, and collaborate with cross-functional teams to ensure patient safety and regulatory compliance.

The role involves leading investigations, trend analysis, risk updates (ISO 14971), and continuous improvement of surveillance processes in a regulated environment.

Qualifications

• Bachelor’s degree in engineering or related field required.
• 3–5 years of post-market surveillance experience in medical devices.
• Strong knowledge of medical device regulations and post‑market requirements.
• Detail oriented with ability to manage complex documentation in regulated environments.
• Strong analytical, communication and cross‑functional collaboration skills.
• Excellent technical writing, communication and cross‑functional collaboration skills.

Responsibilities

• Lead investigations of customer complaints, product failures and adverse events to determine root cause.
• Perform trend analysis using complaint and service data to identify quality issues.
• Apply statistics and quality engineering tools to evaluate product performance.
• Monitor device post-market performance to ensure regulatory compliance and safety.
• Collaborate with customers to gather accurate complaint information for failure analysis.
• Support risk management activities, including ISO 14971 updates based on post‑market data.
• Develop and improve post‑market surveillance procedures and processes for compliance.
• Maintain audit-ready records of surveillance activities and findings.
• Communicate with regulatory agencies and respond to inquiries.

Skills

Analytical skills

Cross-functional collaboration

Technical writing

Attention to detail

Regulatory knowledge

Communication

Education

Bachelor’s degree in engineering or related field

Tools

Medical device complaint handling systems

Job description

RadNet, Inc. is seeking a Post Market Surveillance Quality Engineer in Marlborough, MA to monitor IPG Medical devices post-market, drive CAPA, and collaborate with cross-functional teams to ensure patient safety and regulatory compliance.

The role involves leading investigations, trend analysis, risk updates (ISO 14971), and continuous improvement of surveillance processes in a regulated environment.