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 107,000 colleagues serve people in more than 160 countries

JOB DESCRIPTION:

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. Thats why were focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. Were revolutionizing the way people monitor their glucose levels with our new sensing technology.

Our location in Alameda, CA currently has an opportunity for a Section Manager Product QA.

The Section Manager for Product QA is responsible for facilitation of resources that analyze, evaluate, and control risk decisions utilizing common practices throughout the quality system to achieve the Division quality policies. This includes post-production risk evaluation processes and risk impact assessment for distributed product and corrective and preventive actions for the purpose of reducing or eliminating risk such as Quality Holds, Quality Technical communications, and Field Actions as needed. Escalate customer complaints, exception reports, manufacturing deviations and regulatory requirements against existing historical analysis to identify new issues, execute product control, risk evaluation and field action decisions with cross functional teams, escalating supply interruptions to senior management as appropriate, product
control processes, managing the quality hold processes for ADC and closure of all quality holds to resume product supply.

WHAT YOU'LL DO:

* Responsible for implementing and maintaining the effectiveness of the quality system.

* Manages and tracks risk evaluation activities documentation once a quality issue has been identified for distributed product to closure which includes, initiation, cross-functional reviews between manufacturing/development Teams and senior management.

* Develop area goals and align with business objectives.

* Ensures compliance to site and Division policies, process, and procedures as applicable.

* Manage and assist staff to ensure Risk Evaluations, Quality Hold notifications, Advisory Notices and Field Actions are appropriately initiated, reviewed, approved, tracked and closed within acceptable time frames.

* Measures and reports performance of personnel and process relative to targets.

* Develops and implements project plans, ensures milestones are met and prioritizes resource workload as required to meet commitments.

* Delegates responsibility and authority to department members on the basis of work and opportunities for development.

* Monitors progress ensuring deadlines are met and results achieved.

EDUCATION AND EXPERIENCE YOULL BRING

Bachelors degree, preferably in a science or engineering discipline. Advanced degree a plus, but not required. Knowledge and experience of Quality Systems Regulations, 21CFR820 and ISO standard 13485. Minimum 5 years prior experience in the medical device field. 3 years management, supervisory or team leadership experience required.

WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:

* A fast-paced work environment where your contribution is essential to success
* 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:

CHMN Office of the Chairman

LOCATION:

United States > Alameda : 1360-1380 South Loop Road

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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