Post-Market Quality Engineer: Drive Device Safety & CAPA

Kaye/Bassman International; Massachusetts; On-site; USD 90,000 - 130,000; Full time

Job summary

Kaye/Bassman International is recruiting for a Post Market Surveillance Quality Engineer for a leading medical device innovator in Massachusetts. The role monitors device performance, safety, and quality through the post‑market lifecycle and leads complaint investigations and adverse event evaluations.

You will apply ISO 14971 risk management, MDR/FDA requirements, and statistical methods to drive CAPA and continuous improvement, collaborating with customers and cross‑functional teams to

Qualifications

• Bachelor's degree in engineering or a related field.
• Minimum of 3 years' experience in complaint handling/post‑market surveillance in medical devices.
• Familiarity with MDR filing processes and FDA 21 CFR 820/803.
• Strong knowledge of medical device regulations and post‑market surveillance requirements.
• ISO 13485 and ISO 14971 knowledge is a plus.
• Attention to detail in regulated documentation.

Responsibilities

• Lead investigations of complaints, product failures, and adverse events to determine root cause.
• Perform trend analysis of complaint and service data to identify quality issues.
• Apply statistical methods and quality tools to evaluate product performance.
• Monitor device performance in post‑market settings to ensure regulatory compliance.
• Collaborate with customers to obtain complete complaint information and support failure analysis.
• Develop and maintain post‑market surveillance procedures for regulatory compliance.
• Prepare audit-ready records and participate in internal and external audits.
• Promote patient safety and drive continuous improvement across the organization.

Skills

Quality engineering

Regulatory knowledge

Analytical skills

Cross-functional collaboration

Technical writing

Education

Bachelor's degree in engineering

Job description

Kaye/Bassman International is recruiting for a Post Market Surveillance Quality Engineer for a leading medical device innovator in Massachusetts. The role monitors device performance, safety, and quality through the post‑market lifecycle and leads complaint investigations and adverse event evaluations.

You will apply ISO 14971 risk management, MDR/FDA requirements, and statistical methods to drive CAPA and continuous improvement, collaborating with customers and cross‑functional teams to