Abbott Sr. Manager Quality Management Review and Metrics in Pleasanton, California

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.

JOB DESCRIPTION:

This position is responsible for developing, establishing and maintaining quality systems programs, policies, processes, procedures, training materials, and controls enhancing the performance and quality of products and the divisional capability to demonstrate conformance to established standards and agency regulations.

Job Duties:

  • Provide overall Quality Systems leadership including:

  • Direction and oversight of Global Divisional Management Review process

  • Direction and oversight of Quality Metric data gathering, tracking, and reporting

  • Provide expert level guidance and direction of the Quality Systems Body-of-Knowledge .

  • Aggressively identify opportunities to apply, continuously improve, and redefine quality systems and controls for all divisional product-related processes in accordance with applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.

  • Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.

  • Provide influential leadership with International sites to drive proactive quality system improvements.

  • Represent Quality Systems as required in support of cross-functional divisional projects.

  • Identify Quality Initiatives and lead cross-functional teams to complete them.

  • In coordination with the divisional training function, oversee, develop and provide training to divisional personnel on Quality Management System topic training.

  • Provide diligent and fact-based communication to Executive Management team, peers, and team on Quality Systems initiatives and changes.

  • Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.

  • Provide guidance, leadership and organizational support for Product Development projects.

  • Provide management and development of assigned Quality Systems staff.

  • Be an effective member of the cross-functional Manager organization to foster continuous quality compliance, cost, and predictive measures improvements.

  • Liaison with Global Quality organization on QMS initiatives.

  • Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.

  • Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization.

  • This position will serve as a functional representative for organizational initiatives potentially impacting or affecting the QMS.

  • Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.

  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

  • Performs other related duties and responsibilities, on occasion, as assigned.

General Qualifications

  • 4 year degree or equivalent industry-related experience, Master’s preferred.

  • 7+ years in quality functional roles desired with at least 3 years of direct management and supervision of personnel and resources.

  • Demonstrated organizational influence to include, but not limited to: compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction.

  • Medical Device manufacturing experience (FDA Class III preferred).

  • Unwavering ethical resilience, high standard of personal integrity, and a non-financially encumbered moral compass.

  • Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies required.

  • Experience working in a broader enterprise/cross division business unit model preferred.

  • Ability to work in a highly matrixed and geographically diverse business environment.

  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

  • Ability to work effectively within a team in a fast-paced changing environment.

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

  • Multi-tasks, prioritizes and meets deadlines in timely manner.

  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.

  • Ability to travel approximately 25%, including internationally.

  • Willingness to relocate and be open to global mobility assignments.

JOB FAMILY:

Operations Quality

DIVISION:

ASJM Abbott St. Jude Medical

LOCATION:

United States of America > Plymouth 5050 Nathan Lane > S4509 : 5050 Nathan Lane N.

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

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

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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