Job 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 109,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Our location in Lake County, Illinois currently has an opportunity for a Quality Manager, Technical Design.

We create a variety of breakthrough products at the highest level of quality. This Manager will be a key factor in continuing that track record. This individual will provide technical design expertise in the review of regulated product submissions and enterprise-wide support of Abbotts Quality System, including consultation on quality and regulatory compliance. This includes technical support and product submission reviews. This is a hands-on, in-depth leadership role that requires a strong technical understanding of design and development efforts for regulated medical devices including in vitro diagnostics.

As a key member of the Corporate organization, this Manager will serve as a liaison and technical expert to the Abbott businesses developing a strategic framework and a technical review process, then implemented to deliver objective feedback and direction for ongoing product submissions. In addition, this role will develop a standard interpretation of regulations and technical standards applicable to product submissions, facilitate policy development and deployment to the Abbott businesses, properly influence regulations through industry groups and other channels, provide oversight for FDA communications regarding compliance issues, and advise senior management as to impact of regulatory changes.

WHAT YOULL DO

* Organize, review, and comprehend large volumes of complex and technical data in a condensed timeframe as it relates to product design and development efforts and regulatory submissions.
* Analyze and develop recommendations for actions necessary to support product submissions.
* Effectively communicate, both verbally and in writing, the feedback of product submission review at all levels of the organization.
* Lead and facilitate technical meetings in support of the product submission reviews.
* Develop training, seminars, workshops and/or other appropriate forums to share information and learnings acquired from the technical review process for product submissions.
* Travel up to 25%, both domestic and international.

EDUCATION AND EXPERIENCE YOULL BRING

* Bachelors degree in technical or science related discipline is required. Advanced degree is preferred.
* 4+ years of managing technical design programs in a product quality and/or regulatory function, ideally in a regulated healthcare industry.
* Must possess working knowledge and experience of quality system requirements and design controls, ideally in a medical devices/diagnostics field.
* Must possess acute understanding of the regulatory submissions process and required content.
* Must have sound knowledge of and/or proven track record in product development and manufacturing processes, as well as experience working in product development teams either in R&D, Technical Support or Design Quality.

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: www.abbottbenefits.com

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.

JOB FAMILY:

Operations Quality

DIVISION:

AQR Abbott Quality and Regulatory

LOCATION:

United States > Abbott Park : AP52 Floor-1

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

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