Sr. Quality Engineer I- Combination Products

Responsibilities

• Lead quality engineering for combination product development programs with focus on design controls and risk management
• Partner with device engineering on design verification, validation, and technology transfer activities
• Ensure regulatory compliance with applicable FDA and ISO standards throughout product lifecycle
• Interface with cross-functional teams, contract manufacturers, and suppliers to resolve quality and technical issues
• Develop, review, and approve controlled documentation including protocols, risk analyses, and test methods

Requirements

• Bachelor's degree in Engineering or science with 6+ years relevant experience, or Master's with 4+ years
• Demonstrated quality assurance experience with medical devices or drug-device combination products
• Strong verbal, written, and interpersonal communication skills with cross-functional influence ability
• Knowledge of FDA 21 CFR Part 820, Part 4, ISO 13485, and ISO 14971 regulatory requirements
• Project management and process improvement capabilities in regulated environments
• Statistical methods proficiency including capability analysis, MSA, and Gage R&R
• Advanced risk management expertise per ISO 14971, including FMEA and hazard analysis

Compensation: $136,340–$176,440 base