Quality Section Leader

hace 3 semanas

Alajuela, Costa Rica Abbott Laboratories A tiempo completo

**About Abbott Quality Section Leader**

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 will have access to:

- Career development with an international company where you can grow the career you dream of.
- 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.

**The Opportunity**

This position works out of our Alajuela location in the Electrophysiology (EP) business. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

As the **Quality Section Leader**, you’ll be 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 Do**
- Management and development of Quality Engineers and Technicians.
- Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization with international partner site to drive proactive quality improvements.
- Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
- Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility, providing proactive, diligent, and fact-based communication to Sr. Management team, peers and team.
- Define and implement Process Control & Monitoring systems as well as maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
- 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.
- Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization.
- Verify adherence of New Product Introductions to the established Quality System, international standards and agency regulations.

**Required Qualifications**
- Bachelor's degree (4-year degree) in STEM field or Bachelor's degree in Business Administration.
- 5 to 7 years of experience with preferably 4+ years in a quality engineering roles.
- Solid knowledge of and experience working with international quality regulations, including US 21 CFR 820 (QSR) and ISO 13485.
- Demonstrated and impactful experience with product and process qualification and validation, process improvement, lean and six sigma methodologies, process control and monitoring (SPC).
- Demonstrated results in nonconformance management and reduction, value improvement, risk reduction, and cost containment.
- Fully Bilingual (English and Spanish) / Required

**Preferred Qualifications**
- 5 - 7 years in Quality with roles of increasing responsibility, impact, and scope within a manufacturing support environment, preferred.
- FDA Class II or Class III medical device experience, preferred
- Quality or Lean Certifications (i.e. Six Sigma Belt, ASQ CQE/CRE/CQM) preferred.
- Ability to travel to support domestic and international manufacturing sites (up to 15%).

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