Early-Career Medical Device Complaints Engineer

DEKA Research & Development Corp.; Manchester (NH); On-site; USD 55,000 - 75,000; Full time

Job summary

Millyard Advanced Medical Products is hiring a Junior Product Complaints Engineer in Manchester, NH, to review and evaluate complaints related to potential medical device issues within a dynamic R&D environment. The role reports to the Product Complaints Manager and has high visibility and direct impact on the Quality Management System.

Responsibilities include regulatory-aligned complaint investigations, documentation, and decisions on reporting to agencies, plus collaboration with third-party

Qualifications

• 4-year biomedical engineering degree; OR 2-year biomedical engineering degree and 2+ year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis.
• Experience in complaint handling or quality engineering preferred.
• Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
• Experience with Salesforce is preferred.

Responsibilities

• Review complaints related to potential medical device issues.
• Perform product complaint evaluations with minimal direction, utilizing experience and product knowledge.
• Ensure complaint documentation follows Good Documentation Practices; meets QMS requirements; and complies with FDA regulations and other regulatory requirements.
• Identify and make sound decisions regarding medical device reporting to regulatory agencies.
• Interface with Third Party Manufacturers, health care professionals, internal customers, and regulatory agencies.
• Participate in audits and CAPA investigations as they relate to complaint handling.
• Work with the forensic investigation team to align product investigations related to complaints.
• Generate reports to identify areas of process improvement.
• Develop product training aids.
• Contribute independently while also collaborating with other team members and departments needing product complaint information.
• Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors.
• Serve as a subject matter expert on complaint handling.
• Perform other related duties as assigned under management supervision.

Skills

Complaint handling

Quality engineering

FDA QMS knowledge

Time management

Technical writing

Cross-functional teamwork

Independent work

Education

B.S. Biomedical Engineering

A.S. Biomedical Engineering + 2+ years cGMP experience

Tools

Salesforce

Job description

Millyard Advanced Medical Products is hiring a Junior Product Complaints Engineer in Manchester, NH, to review and evaluate complaints related to potential medical device issues within a dynamic R&D environment. The role reports to the Product Complaints Manager and has high visibility and direct impact on the Quality Management System.

Responsibilities include regulatory-aligned complaint investigations, documentation, and decisions on reporting to agencies, plus collaboration with third-party