Quality Manager

Quality Manager 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 of which you dream.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• 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.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

This position works out of our Westfield, IN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

The Quality Manager is accountable for the Quality Operations Organization and leads a team of Quality supervisors/technicians/inspectors/specialists to support Manufacturing, Supplier Development, New Product Development, Distribution/Warehouse Value Added Services, and Quality Systems. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements.

• Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.

• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.

• Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.

• Interacts with internal and external stakeholders, by meeting regularly, responding to requests and explaining procedures as applicable.

• Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.

• Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.

• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).

• Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.

• Translates department goals into individual objectives and KPI.

• Identifies, develops and implements processes to improve department performance.

• Monitors departmental activities and records to ensure compliance.

• Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools.

• May also direct work assignments for quality control auditors.

• May also direct Quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & engineers.

• May own, author, review, approve, and support CAPA activities.

• Supports, actively engages, and may escort internal and external auditors (BSI, FDA, KGMP, etc).

• Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.

• Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.

• Promotes the attainment of group goals by selecting, motivating, and training capable staff

• Provides…