Quality Manager
hace 1 día
**Quality Manager**
**About Abbott**
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 Costa Rica - Coyol Alajuela location in the Electrophysiology business Unit.
As the Quality Manager, you’ll 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. This individual develops and executes the required strategies and plans to improve product and process quality in order to deliver planned business results and assure compliance with FDA and ISO regulations and any country specific regulation were product is distributed. This position is responsible for collecting and documenting management review information, conducting regular meetings, and reporting the information to the plant’s leadership team and the appropriate Divisional Management Representative.
**What You’ll Do**
- Management and development of applicable Quality department personnel
- Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.
- Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
- Oversee the facility’s implementation of and compliance with Nonconformance and CAPA systems.
- Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
- Verify adherence of New Product Introductions to the established Quality System, international standards and agency regulations.
**Required **Qualifications**
- B.S. in Engineering, Science or Technical Field, or Bachelor's degree in Business Administration.
- 7 years of experience in a regulated industry, with 5 years in Quality roles.
- Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies required.
- 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.
- Ability to travel to support domestic and international manufacturing sites, if is require.
- Excellent English level.
**Preferred **Qualifications**
- Master´s degree.
- 5+ 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).
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.
**Divisional Information**
Medical Devices
General Medical Devices:
Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
**Electrophysiology**
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.
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