What are the responsibilities and job description for the Senior Quality Engineer position at Finish Line Staffing Services?
Must be a US Citizen or Green card holder
Key Responsibilities
Serve as the Design Assurance (DA) lead on product development projects
• Ensure compliance with internal design control and risk management procedures aligned with FDA and ISO standards
• Lead cross-functional teams in risk management activities (hazard analyses, risk evaluations, FMEAs, RMP/RMR/RMF)
• Provide guidance to project teams to ensure effective implementation of design control requirements
• Support Design Verification & Validation (V&V) strategies and best practices
Qualifications
- Bachelor’s degree in Engineering or related technical field
- • 5–8 years of Design Assurance experience in medical device or life sciences
- • Experience with NPI and design transfer
- • Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971:2019
- • Familiarity with IEC 62304, IEC 60601, ISO 10993 preferred
- • Experience with regulatory documentation