Design Controls Manager

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

About Abbott

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That's why we're focused on helping people with diabetes manage their health more effectively and comfortably, revolutionizing the way people monitor their glucose levels with our new sensing technology.

Our location in Alameda, CA, currently has an opportunity for a Design Controls Manager.

Summary : Design Controls subject matter expert managing process and compliance to process for a Fortune 100 R&D team. Interfaces directly with RA/QA 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 and maintaining the ability to process releases of both hardware and software, product and non-product, medical device and non-medical device, in a timely manner.

This is an exciting opportunity to be a recognized expert and guide modern design controls and product development practices at a Fortune 100 company.

WHAT YOU'LL DO
  • Partner in optimizing, streamlining, and increasing compliance with design control requirements for Abbott Diabetes Care products: hardware, embedded software, and SaMD.
  • 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-confirmances.
  • 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 IEC60601, IEC62304, ISO13485, ISO14971, IEC62366, 21CFRPart820, MDSAP, Agile 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.
  • Partner with R&D resources to ensure alignment and compliance when choosing and implementing software tools for design and development activities.
  • Participate in external audits (FDA, ISO, Partner) as a representative of the R&D function and design controls expert.


EDUCATION AND EXPERIENCE YOU'LL BRING
  • Required: 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 products.
  • FDA audit participation experience.
  • Experience auditing design records.
  • 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.


  • 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


WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career.

We offer:
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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