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Design Controls Manager
Location
California
Posted
131 days ago
Salary
$99.3K - $198.7K / year
Seniority
Senior
Job Description
Design Controls Manager
Abbott
• Design Controls subject matter expert managing process and compliance to process supporting Abbott Diabetes Care R&D team. • 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. • Develop and deliver 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. • Audit design records as required to ensure conformance; work with R&D and QA teams to evaluate and remediate non-conformances. • Perform gap analyses to international regulatory standards and guidance and propose policy and procedure updates to conform. • Maintain expertise in global design controls and design and development standards and guidance including ISO13485, ISO14971, 21CFRPart820, MDSAP, IEC60601, IEC62304, IEC62366, Agile software development, etc. • Train and mentor R&D and QA resources in subject matter expertise to ensure alignment and acceptance of organization with policies and procedures. • Participate in audits (FDA, ISO, Partner, internal) as a R&D representative and design controls expert. • Build technical knowledge of the business product portfolio and maintain awareness of program initiatives and product ecosystem developments. • Partner with R&D resources to ensure alignment and compliance when choosing and implementing software tools for design and development activities.
Job 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.
- Travel will be 25% including periodic international travel.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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