Perform QA activities related to Combination Product and Medical Device Design Transfer and Change
Ensure compliance with company policies and procedures
Perform design control and risk management activities according to AbbVie's Quality System
Maintain DHF documentation
Partner within Quality and Operations to ensure design control documentation (Risk Management
Perform 3rd party supplier management activities such as review 3rd party design control activities

🎯 Requirements

Bachelor’s degree in engineering, science or other technical areas
6+ years of relevant experience in the medical device industry; 4+ years of Quality Assurance
English proficiency: B2+
Strong understanding of regulations and standards affecting combination products and medical devices
Working knowledge of 21 CFR 820, EU MDR 2017/745, ISO 13485, and ISO 14971
Working knowledge of Design Control per 21 CFR 820.30

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