Quality Assurance Manager
hace 2 meses
About Abbott
Abbott is a global healthcare leader creating innovative solutions to improve people's health. We anticipate changes in medical science and technology, driving groundbreaking research and development.
Working at Abbott
At Abbott, you can do meaningful work that makes a difference, grow and learn, care for yourself and family, and live a full life. You will have access to:
Career Development
- International company with opportunities to grow your career.
- Company recognized as a great place to work in dozens of countries and named one of the most admired companies by Fortune.
- Company with diverse, inclusive, and supportive work environment.
The Opportunity
This position is based in Costa Rica's Alajuela location in the Structural Heart Division. Abbott's business purpose is to restore health and improve quality of life through innovative device and management solutions for structural heart disease.
Job Responsibilities
- Develop, establish, and maintain quality assurance programs, policies, processes, procedures, and controls to ensure product quality and performance meet established standards and regulations.
- Lead and manage Quality Engineers and Technicians.
- Provide guidance and leadership on quality engineering best practices.
- Ensure compliance with all applicable internal and external quality regulations, including US 21 CFR 820 (QSR) and ISO 13485.
- Identify opportunities to improve quality, reduce risks, and contain costs.
Requirements
- Bachelor's Degree in Engineering, Science, or Technical Field, or Business Administration.
- 5-7 years of experience in quality engineering roles, preferably with international quality regulations experience.
- Strong knowledge of quality regulations, including US 21 CFR 820 (QSR) and ISO 13485.
- Experience with product and process qualification, validation, process improvement, lean, and six sigma methodologies.
- Results-driven and impactful experience in nonconformance management, value improvement, risk reduction, and cost containment.
- Excellent English language skills.
Preferred Qualifications
- 5-7 years of quality experience with increasing responsibility, impact, and scope in a manufacturing support environment.
- Experience with FDA Class II or Class III medical devices.
- Quality or Lean certifications, such as Six Sigma Belt or ASQ CQE/CRE/CQM.
- Ability to travel up to 15% to support domestic and international manufacturing sites.
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