Manager Quality Assurance

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.

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity:

We have an immediate opportunity for a Manager Quality Assurance in our Lake County, IL location.

What You'll Work On:

Primary Job Function:

The function of the Manager, Quality Business Support - Technical Design Quality is to provide corporate-wide support of Abbott's Quality System and product submissions.

The candidate must possess a working knowledge of Quality System requirements, design controls and risk management, as well as an understanding of the US IVD regulatory submissions process and required contents. The candidate must have experience in product design quality and technical (R&D, Technical Support, or manufacturing) roles.

The primary activities and responsibilities expected of this position include providing support for US IVD product submission reviews, and consultation in matters of Quality System and regulatory compliance. This role will serve as a corporate liaison and quality and technical expert to the Abbott businesses, developing and providing a strategic framework through the technical review process implemented to deliver objective feedback and direction for product submissions.

This role is responsible for:

• Developing a standard interpretation of regulatory guidance and feedback for Abbott and facilitating deployment to the divisions.
• Developing, assessing, and communicating key metrics related to product submissions and facilitating implementation of best practices in design and development.
• Providing senior management with assessment of submission risks and potential impacts to both regulatory submissions and sustainability of commercialized products.

The candidate must be able to:

• Organize, perform detailed review, and comprehend large volumes of complex and technical data in a condensed timeframe.
• Assess collective or broader impact of individual challenges identified within reviews.
• Analyze and develop recommendations for actions necessary to support product submissions based on identified risks.
• Effectively communicate, both verbally and in writing, the product submission review feedback to all levels of the organization.
• Lead and facilitate both AQR internal and external meetings to support the review of the product submissions.
• Establish, evaluate and communicate submission review process metrics based on Power BI analysis.
• Develop training, seminars, workshops and/or other appropriate forums to share information and learnings acquired from the technical review process for product submissions.
• Provide ongoing coaching to Abbott businesses throughout the design and development process to promote consistency and standardization.
• Monitor new or changing regulatory requirements. Understand and apply industry standards and guidance (e.g. CLSI).
• Understand and apply all Quality System requirements as they impact policies, procedures, processes, product design, and submission requirements.
• Travel up to 10%, both domestic and international.

Position Accountability / Scope:

The position has the responsibility and accountability of providing direction with oversight from the Director, Technical Design Quality.

This unique position encompasses multi-site and multi-divisional responsibilities for numerous facets of Design Quality, Technical and Regulatory in the Corporation.

The position will be responsible for sensitive and critical negotiations, internally as well as potentially with outside bodies, on an ongoing basis.

Required Qualifications:

• A Bachelor's degree in technical or science related discipline is required.
• 6+ years of managing design quality and technical programs and projects in regulated healthcare industry, preferably with experience in the IVD industry.

Preferred Qualifications:

• Advanced degree is preferred, but not required.

Apply Now

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.

The base pay for this position is
$127,300.00 - $254,700.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
AQR Abbott Quality and Regulatory

LOCATION:
United States > Abbott Park : AP52

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
No

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf