Lead Product Complaints Engineer – Medical Devices

DEKA Research & Development Corp.; Manchester (NH); On-site; USD 110,000 - 140,000; Full time

Job summary

DEKA Research & Development Corp. seeks a Product Complaints Engineer - Team Lead to join Millyard Advanced Medical Products in Manchester, NH.

The role focuses on leading complaint investigations, maintaining regulatory documentation, and driving improvements in the QMS within a fast-paced medical device environment. The position reports to the Product Complaints Manager and involves collaboration with cross-functional teams to ensure timely, accurate reporting and CAPA handling.

Qualifications

• 4-year engineering degree in biomedical engineering with 3+ years in a cGMP environment for complaint handling or reporting.
• Or a 2-year degree with 5+ years of relevant cGMP experience.
• Knowledge of FDA QMS requirements (21 CFR 803, 820, 211) preferred.
• Salesforce experience preferred.
• Strong documentation, time management, and cross-functional collaboration.

Responsibilities

• Lead a small team of Product Complaints Engineers focused on one or more medical devices.
• Review complaints related to potential device-related issues.
• Perform product complaint evaluations with minimal direction.
• Ensure complaint documentation complies with FDA regulations and QMS.
• Interface with manufacturers, healthcare professionals, and regulators.
• Participate in audits and CAPA investigations related to complaints.
• Work with forensic investigations to align product findings.
• Author procedures and work instructions and establish training programs.
• Contribute independently and with team members; maintain professional communication.

Skills

Time management

Team collaboration

Problem solving

Communication skills

Independent work

Attention to detail

Education

Bachelors in Biomedical Engineering

Associate degree with 5+ years experience in cGMP

Tools

Salesforce

Job description

DEKA Research & Development Corp. seeks a Product Complaints Engineer - Team Lead to join Millyard Advanced Medical Products in Manchester, NH.

The role focuses on leading complaint investigations, maintaining regulatory documentation, and driving improvements in the QMS within a fast-paced medical device environment. The position reports to the Product Complaints Manager and involves collaboration with cross-functional teams to ensure timely, accurate reporting and CAPA handling.