Lead Designer in Hargrove's Architectural division overseeing architectural deliverables. Manage team with focus on quality, budget, and deadlines.
About the role
- Design Controls Manager optimizing design control compliance and process management for Abbott Diabetes Care. Ensuring global regulatory standards and leading cross-functional teams in process improvement.
Responsibilities
- Design Controls subject matter expert managing process and compliance to process supporting Abbott Diabetes Care R&D team.
- Interface directly with Regulatory, Quality, Operations, and R&D directors, managers and SMEs to ensure that the design controls and related processes meet global regulatory standards and guidance while promoting efficiency.
- Partner in optimizing, streamlining, and increasing compliance with design control requirements for Abbott Diabetes Care products: hardware, embedded software, and SaMD.
- Lead process development and process improvement projects with world-wide cross-functional teams.
- Conduct training on general design controls and develop training specific to process changes.
- Demonstrate leadership in change management practices.
- Ensure conformity of processes and records to global regulatory standards and internal policies and procedures.
Requirements
- BS in Management, Engineering or Science preferred, or equivalent combination of work experience and education.
- 5 + years Quality or R&D experience at a medical device company
- In-depth knowledge of the Quality System Regulation (QSR), ISO 13485, MDSAP, and EU Medical Device Regulation.
- High level of knowledge of all QMS sub systems including: CAPA, internal audits, risk management, design control, verification and validation, internal and external audits, management responsibility, training.
- Experience leading a design and/or design processes in a medical device company which includes software as a medical device product.
- Demonstrated leadership through influence.
- Must be able to communicate globally and create followership.
- Must possess strong written, verbal and interpersonal communication skills and work independently as well as in close collaboration with others.
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Flexible working arrangements
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