Manager, Quality Engineering
AbbottAbout the role
JOB DESCRIPTION:
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of .
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
The Opportunity
This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division.
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Manager, Quality Engineering is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations.
What You’ll Work On
Provide Quality Engineering leadership in direct support of medical device manufacturing.
Management and development of Quality Engineers and Technicians.
Manage the activities of the Post-Production Quality Engineering team.
Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.
Aggressively identify opportunities to proactively assure compliance to all 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.
Define and implement superior Process Control & Monitoring systems for KPIV and KPOV throughout the product lines – Critical Parameter Management.
Provide influential peer leadership with international partner site to drive proactive quality improvements.
Identify Quality Initiatives and lead cross-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.
Oversee 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 disciplined problem solving throughout the organization.
Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirem
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