Emerging Medical Device Complaints Engineer

DEKA Research and Development; Manchester (NH); On-site; USD 60,000 - 80,000; Full time

Job summary

DEKA Research and Development in Manchester, NH, seeks a qualified individual to assess complaints regarding medical devices. The role requires strong knowledge of FDA regulations and experience with complaint handling. Candidates should possess a biomedical engineering degree and have excellent problem-solving as well as communication skills.

The position offers opportunities to work in a fast-paced environment alongside regulatory agencies and healthcare professionals, ensuring high standards in product evaluations and documentation.

Qualifications

• 4-year biomedical engineering degree or equivalent with relevant experience in a cGMP environment.
• Experience in complaint handling or quality engineering preferred.
• Knowledge of FDA requirements for Quality Systems and Medical Device Reporting.

Responsibilities

• Review complaints related to medical device issues.
• Perform product complaint evaluations and ensure compliance.
• Interface with Third Party Manufacturers and regulatory agencies.

Skills

Biomedical engineering degree

Experience in complaint handling

Knowledge of FDA regulations

Experience with SalesForce

Strong motivation

Exceptional time management

Good problem-solving skills

Solid communication skills

Sound technical writing skills

Ability to work independently

Education

4-year biomedical engineering degree

2-year biomedical engineering degree with relevant experience

Tools

SalesForce

Job description

DEKA Research and Development in Manchester, NH, seeks a qualified individual to assess complaints regarding medical devices. The role requires strong knowledge of FDA regulations and experience with complaint handling. Candidates should possess a biomedical engineering degree and have excellent problem-solving as well as communication skills.

The position offers opportunities to work in a fast-paced environment alongside regulatory agencies and healthcare professionals, ensuring high standards in product evaluations and documentation.