Senior Quality Assurance Manager
hace 2 meses
About Abbott
About Abbott
Abbott is a leading healthcare company that creates innovative solutions to improve people's health. We anticipate and respond to changes in medical science and technology, striving for excellence in all we do.
Working at Abbott
We offer a dynamic work environment where you can 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 division. 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 Senior Quality Assurance Manager, you will 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.
Job Responsibilities
- Management and development of Quality Engineers and Technicians.
- Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.
- 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.
- Define and implement Process Control & Monitoring systems.
Required Qualifications
- Bachelor's Degree in Engineering, Science, or Technical Field, or Bachelor's degree in Business Administration.
- 5 to 7 years of experience with preferably 4+ years in a quality engineering role.
- 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.
- Demonstrated organizational influence to include, but not limited to: compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction.
- Excellent English Level.
Estimated Salary
$90,000 - $120,000 per year, based on experience and qualifications.
Shift B: Monday - Friday 3:30 pm - 10:00pm. Saturday: 8:00am - 3:30pm
Preferred Qualifications
- 5 - 7 years in Quality with roles of increasing responsibility, impact, and scope within a manufacturing support environment.
- FDA Class II or Class III medical device experience.
- Quality or Lean Certifications (i.e. Six Sigma Belt, ASQ CQE/CRE/CQM).
- Ability to travel to support domestic and international manufacturing sites (up to 15%).
- Desired previous experience in NPIs.
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