Description:
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 114,000 colleagues serve people in more than 160 countries.
We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
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Career development with an international company where you can grow the career you dream of.
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Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
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An excellent retirement savings plan with high employer contribution
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Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
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A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
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A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
THE OPPORTUNITY
This Design Controls Manager position can work out in one of the following locations: Alameda (CA), Bend (OR), Chicago (IL), or Orlando (FL) .
Design Controls Manager is a 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
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Partner in optimizing, streamlining, and increasing compliance with design control requirements for Abbott Diabetes Care products: hardware, embedded software, and SaMD.
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Interface with appropriate internal and external resources (regulatory, customers, etc.) to ensure development programs meet regulatory and customer requirements.
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Participates in review boards for intellectual property, CAPA, complaints, business unit planning, and others as necessary.
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Ensure conformity of processes and records to global regulatory standards and internal policies and procedures.
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Audit design records as required to ensure conformance; work with R&D and QA teams to evaluate and remediate non-conformances.
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Review and provide functional approval for project and quality system documentation.
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Perform gap analyses to international regulatory standards and guidance and propose policy and procedure updates to conform.
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Maintain expertise in global design controls and design and development standards and guidance including IEC60601, IEC62304, ISO13485, ISO14971, IEC62366, 21CFRPart820, MDSAP, Agile development, etc.
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Train and mentor R&D and QA resources in subject matter expertise to ensure alignment and acceptance of organization with policies and procedures.
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Partner with R&D resources to ensure alignment and compliance when choosing and implementing software tools for design and development activities.
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Participate in external audits (FDA, ISO, Partner) as a representative of the R&D function and design controls expert.
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Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
QUALIFICATIONS
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Bachelor's Degree in a Technical field, preferably mechanical, chemical, biomedical, industrial, or quality engineering.
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Minimum 10 years of Medical device development and/or other highly regulated industry.
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In-depth knowledge of the Quality System Regulation (QSR), ISO 13485, MDSAP, and EU
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High level of knowledge of all QMS subsystems, including CAPA, internal audits, risk management, design control, verification and validation, internal and external audits
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Experience auditing design records.
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Strong verbal and written communication skills, with the ability to effectively communicate at multiple levels in the organization.
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Multitask, prioritize and meet deadlines in a timely manner.
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Strong organizational and follow-up skills, as well as attention to detail.
PREFERRED
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Experience leading design and/or design processes in a medical device company that includes software as a medical device product.
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FDA audit participation experience.
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Medical Device Regulation experience.
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Demonstrated leadership through influence.
Apply Now
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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
The base pay for this position is $125,300.00 – $250,700.00. In specific locations, the pay range may vary from the range posted.