Product Complaints Engineer - Team Lead

DEKA R&D is seeking a Product Complaints Engineer to lead a team focused on a Medical Device Research and Development environment. This high-visibility role involves reviewing complaints related to potential device issues, performing evaluations, ensuring documentation quality, and identifying regulatory requirements. The position requires collaboration with various stakeholders to improve product complaint handling processes.

Requirements

• 4-year engineering degree, preferably in biomedical engineering
• 3+ years of relevant experience in a cGMP environment
• Knowledge of FDA requirements for Quality Systems and medical device reporting (21 CFR 803, 820, and 211)
• SalesForce experience preferred
• Strong time management and prioritization skills

Benefits

• Competitive salary