Abbott Manager Supplier Quality Engineering in Liberty, South Carolina
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 Quality Engineering leadership in direct support of medical device manufacturing, including:
Management and development of Quality Engineers and Technicians
Manage the activities of the Post-Production Quality Engineering team
Lead the activities of the Supplier Development Quality Engineering and receiving inspection team.
Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization
Passionately find opportunities to assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
Manage the activities of the Supplier Development Quality Engineering and receiving inspection team.
Ensure supplier development activities are implemented in a consistent manner across various site level approved suppliers to ensure business continuity issues.
Be a point of contact for Abbott corporate supplier quality initiatives and ensure initiatives are implemented consistently at a divisional level.
Ensure best in industry risk management principles are implemented at site level, including maintainable close loop risk management system.
Ensure risk management principles are implemented upstream in the supply chain to key suppliers
Enthusiastically identify and run activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
Define and implement Process Control & Monitoring systems for KPIV and KPOV throughout the product lines – Critical Parameter Management
Provide influential peer leadership with partner sites across the business network to drive proactive quality improvements
Identify Quality Initiatives and lead cross-functional teams to complete them
Provide enthusiastic, 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.
Lead 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
Other Duties :
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.
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 preferred.
Class III or II medical device experience
5+ years in quality desired with roles of increasing responsibility, impact, and scope within a manufacturing support environment
Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment
Demonstrated experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC)
Demonstrated and impactful strong project management and people leadership skills 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.
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.
Travel approximately 10-15%, including internationally.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org