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.

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.

Design Controls Manager

Key skills