Senior Medical Device Complaints Engineer - Quality & Regulatory

DEKA Research & Development Corp.; Manchester (NH); Vor Ort; USD 85.000 - 120.000; Vollzeit

Zusammenfassung

Millyard Advanced Medical Products seeks a Product Complaints Engineer to investigate and close medical device complaints within a regulated environment. You will ensure documentation compliance with FDA QSRs and QMS, determine reportability, and interact with regulators, manufacturers, and clinical teams.

In this high-visibility role, you will develop training materials, support CAPA activities, and deliver clear, concise investigation reports.

Qualifikationen

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or related field.
• 3–5 years in a regulated medical device or life sciences setting with complaint investigations and closure responsibilities.
• Experience documenting investigations, determining root cause, and closing records on time.
• Knowledge of FDA QSRs, MDR, and 21 CFR 803/820; ISO 13485 preferred.
• Experience using eQMS and complaint handling platforms; Salesforce experience is a plus.
• Strong technical writing and clear communication skills.

Aufgaben

• Review complaints related to potential medical device issues.
• Perform product complaint evaluations with minimal direction.
• Ensure complaint documentation follows GDocP and QMS; comply with FDA and other regs.
• Identify and decide on reportability to regulatory agencies.
• Interface with manufacturers, healthcare professionals, and regulators.
• Participate in audits and CAPA investigations as they relate to complaints.
• Collaborate with forensic teams on product investigations.
• Generate reports to identify process improvements.
• Develop product training aids.
• Serve as SME on complaint handling.

Kenntnisse

Complaint investigations

Regulatory compliance

FDA Regulations

eQMS systems

Technical writing

Root cause analysis

Ausbildung

Bachelor's in Biomedical Engineering

Tools

Salesforce

MS Office

Jobbeschreibung

Millyard Advanced Medical Products seeks a Product Complaints Engineer to investigate and close medical device complaints within a regulated environment. You will ensure documentation compliance with FDA QSRs and QMS, determine reportability, and interact with regulators, manufacturers, and clinical teams.

In this high-visibility role, you will develop training materials, support CAPA activities, and deliver clear, concise investigation reports.