Medical Device Complaints Engineer — Quality & Regulatory

DEKA Research and Development; Manchester (NH); On-site; USD 75,000 - 105,000; Full time

Job summary

DEKA Research and Development in Manchester, NH seeks a Product Complaints Engineer to join a high-visibility quality-focused team. You will review and investigate medical device complaints and ensure documentation complies with FDA regulations and QMS requirements.

The role emphasizes root-cause analysis, regulatory submissions support, and collaboration with regulatory, engineering, and manufacturing teams to close investigations on time.

Qualifications

• Bachelor's degree in biomedical, mechanical, electrical, quality engineering or related technical discipline is required.
• 3-5 years in a regulated medical device, pharma, or life sciences environment with complaint investigations.
• Experience conducting investigations, determining root cause, and driving records to closure on schedule.
• Familiarity with FDA QSRs (21 CFR 803/820); ISO 13485 is a plus.
• Experience with eQMS and Salesforce is preferred.

Responsibilities

• Review complaints related to potential medical device issues.
• Perform product complaint evaluations with minimal direction.
• Ensure complaint documentation follows Good Documentation Practices and FDA regulations.
• Identify and decide on reportability to regulatory agencies.
• Interface with manufacturers, healthcare professionals, internal customers, and regulators.
• Participate in audits and CAPA investigations related to complaints.
• Collaborate with forensic investigations to align product investigations.
• Generate reports to identify process improvements.
• Develop product training aids and provide cross-team support.

Skills

Strong written and verbal comms

Analytical problem solving

Time management

Self-motivated

Education

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or related technical discipline

Tools

eQMS

Salesforce

Job description

DEKA Research and Development in Manchester, NH seeks a Product Complaints Engineer to join a high-visibility quality-focused team. You will review and investigate medical device complaints and ensure documentation complies with FDA regulations and QMS requirements.

The role emphasizes root-cause analysis, regulatory submissions support, and collaboration with regulatory, engineering, and manufacturing teams to close investigations on time.