Senior Quality Engineer- Design Quality – Lifecycle Management

📋 Description

• QA activities related to Combination Product and Medical Device Design Transfer and Change
• Ensure compliance with company policies and procedures
• Design control and risk management activities per AbbVie Quality System
• Maintain DHF documentation
• Collaborate to ensure design control docs (Risk Management, Traceability/Linkages) & design
• Perform 3rd party supplier management activities (review 3rd party design control activities)

🎯 Requirements

• Bachelor’s degree in engineering, science or other technical areas
• 6+ years in medical device industry; 4+ years QA experience required
• Strong understanding of regulations/standards for combination products and medical devices
• Working knowledge of 21 CFR 820, EU MDR 2017/745, ISO 13485, ISO 14971
• Working knowledge of Design Control per 21 CFR 820.30
• Experience coordinating/planning complex activities; strong problem-solving and interpersonal skills

🎁 Benefits

• Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k)
• Participation in short-term incentive programs
• Note: Equity/bonus details subject to company policy and applicable law