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.
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.
THIS POSITION IS AN ON SITE DAILY ROLE - NO REMOTE
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 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 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.
Education And Experience You’ll Bring
- Bachelors Degree Related field OR an equivalent combination of education and work experience
- Masters Degree Preferred
- Minimum 8-10 years roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired. Industry certification preferred.
- Class III or II medical device experience.
- 3-5 years in a supervisory/leadership role.
- Six Sigma Black Belt strongly preferred.
- ASQ Certified Quality Engineer strongly preferred.
- Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.
- Ability to travel internationally to support international manufacturing sites.
- 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).
- 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.
- Ability to 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.
- Ability to travel approximately 10%, including internationally (only if required)
Apply Now
- Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $112,000.00 – $224,000.00. In specific locations, the pay range may vary from the range posted.
