At Abbott, we're committed to helping people live their 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, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are collaborative, dynamic and progressive. We value people with new ideas who partner with others both internally and externally to take action and accomplish goals.
Impact this role will have on Abbott:
Provide Supplier Quality Engineering leadership in direct support of medical device manufacturing, including:
Management and development of Supplier Quality Engineers and Technicians
Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization
Passionately see opportunities to actively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
Purposefully identify and lead activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
Identify Quality Initiatives and lead multi-functional teams to complete them
Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.
Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
Handle the Nonconformance and Real-time data management portions of the quality System
Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.
Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
Be a champion of Quality, Six Sigma, Lean and focused problem solving throughout the organization
Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and runs 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.
Follows 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.
4 year degree; industry certification or advanced degree, electrical or mechanical engineering preferred.
Class III or II medical device experience (catheter experience preferred).
5+ years in quality desired with roles of increasing responsibility, impact, and scope within a manufacturing support environment.
Champion statistical techniques, including reliability, to design and process areas. (Minitab or equivalent).
Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.
Deep understanding of risk management in design, manufacturing and post-market surveillance.
Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC).
Strong project management and people leadership skills required.
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 to build positive relationships and improve business results.
Work effectively within a team in a dynamic 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.
Able to plan, follow-up and hold others accountable.
Your preferred qualifications and education:
ASQ Certified Quality Engineer strongly preferred (CQE, CRE).
Experience working in a broader enterprise/cross division business unit model preferred.
Ability to travel approximately 5-10%
JOB FAMILY:Operations Quality
DIVISION:CAHF Cardiac Arrhythmias & Heart Failure
LOCATION:United States > Minnesota : 5050 Nathan Lane N.
TRAVEL:Yes, 10 % 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.
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