Associate Medical Device Complaints Engineer

DEKA Research & Development; Manchester, Northern (NH, KY); Hybrid; USD 60,000 - 75,000; Full time

Job summary

DEKA Research & Development is seeking a Junior Product Complaints Engineer to join a dynamic Medical Device R&D environment in Manchester, NH. You will review complaints and perform evaluations, ensuring documentation aligns with FDA regulations and QMS requirements.

You will work with cross-functional teams, identify reporting needs, and help drive CAPA investigations and process improvements in a fast-paced setting.

Qualifications

• 4-year biomedical engineering degree; OR 2-year biomedical engineering degree with 2+ years in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis.
• Experience in complaint handling or quality engineering preferred (school projects and internships considered)
• Knowledge of FDA quality systems requirements and Medical Device Reporting regulations (21 CFR 803, 820, 211) is preferred.

Responsibilities

• Review complaints related to potential medical device issues.
• Perform product complaint evaluations with minimal direction, utilizing product knowledge.

Skills

Complaint handling

Regulatory knowledge

QMS familiarity

Regulatory reporting

Time management

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Biomedical Engineering

2-year Biomedical Engineering degree + 2+ years cGMP experience

Tools

Salesforce

Job description

DEKA Research & Development is seeking a Junior Product Complaints Engineer to join a dynamic Medical Device R&D environment in Manchester, NH. You will review complaints and perform evaluations, ensuring documentation aligns with FDA regulations and QMS requirements.

You will work with cross-functional teams, identify reporting needs, and help drive CAPA investigations and process improvements in a fast-paced setting.