Job Summary

• The Combination Product and Medical Device and Packaging QA Associate will represent Quality in global teams involved in design, development, manufacture and regulatory approval of CSL combination products.
• This role is responsible for ensuring that new product development activities for all CSL combination product projects follow a 21 CFR Part 4 compliant quality system.
• The Medical Device and Packaging QA Staff (Advisor) will serve as a subject matter expert on medical device and combination product requirements in accordance with FDA / MDR regulations, ISO and other standards and industry best practices with the emphasis on Design Control process.

Matching Summary

Salary

Base: $115,000 - $136,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Not specified

Skills & Requirements

Key Requirements

• Bachelor’s degree in mechanical or biomedical engineering, life sciences or relevant discipline
• Minimum 3 years of experience in medical devices or combination products field
• Minimum 2 years practical experience in medical devices R&D Quality: design controls, new product development life cycle, requirement specifications, risk management (including FMEA), validation/verification (V&V), usability / human factor studies, DHFs, design transfer

Work Rights