Quality Manager

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

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 Sylmar, CA 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.

Quality Manager 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

• Management and development of Quality Systems Engineers.

• Administer and lead Corrective/Preventive Action program for all MCS sites (five different locations).

• Oversees the CAPA process from initiation to effectiveness review and ensure the CAPA process is compliant and effective and driving investigations to root cause.

• Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.

• 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 expert level guidance and direction of the CAPA systems Body-of-Knowledge.

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

• Provides subject matter expertise, leadership and training on investigational & Root Cause Analysis techniques, as appropriate, to other CAPA team members and to technical subject matter experts involved in the resolution of quality issues.

• 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.

• Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.

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

• Represent Quality Systems as required in support of cross-functional divisional projects. Identify Quality Initiatives and lead cross-functional teams to complete them.

• Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.

• Produce and analyses trend metrics and reports and establishes further actions, as may be required.

• Approves CAPA investigations and resolution plans, verifies completion of CAPA actions.

• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which a