Medical Device Complaints Engineer – Quality & Compliance

DEKA Research & Development; Manchester (NH); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical innovation firm in Manchester, NH, is seeking a Product Complaints Engineer to address product complaints and ensure compliance with regulatory standards. The ideal candidate will possess a biomedical engineering degree and have experience in a cGMP environment. Responsibilities include conducting evaluations, interfacing with regulatory agencies, and contributing to process improvement initiatives. Strong problem-solving and communication skills are essential for this dynamic role. Join a team dedicated to innovative medical device solutions.

Qualifications

• 4-year biomedical engineering degree or 2-year degree with relevant experience.
• Knowledge of FDA regulations (21 CFR 803, 820, and 211) preferred.
• Experience in a cGMP environment preferred.

Responsibilities

• Review complaints related to medical device issues.
• Perform product complaint evaluations.
• Ensure compliance with regulatory requirements in documentation.
• Make decisions regarding medical device reporting.
• Interface with manufacturers and regulatory agencies.
• Participate in audits and CAPA investigations.
• Work with forensic investigation team on complaints.
• Generate reports for process improvement.
• Develop product training aids.
• Maintain communication with team members and external partners.
• Serve as a subject matter expert on complaints handling.

Skills

Biomedical engineering degree

Knowledge of FDA requirements

SalesForce experience

Time management

Problem-solving skills

Written/verbal communication skills

Technical writing skills

Attention to detail

Education

4-year biomedical engineering degree or equivalent

Tools

SalesForce

Job description

A leading medical innovation firm in Manchester, NH, is seeking a Product Complaints Engineer to address product complaints and ensure compliance with regulatory standards. The ideal candidate will possess a biomedical engineering degree and have experience in a cGMP environment. Responsibilities include conducting evaluations, interfacing with regulatory agencies, and contributing to process improvement initiatives. Strong problem-solving and communication skills are essential for this dynamic role. Join a team dedicated to innovative medical device solutions.