Quality Manager

hace 5 horas

Alajuela, Costa Rica Abbott Laboratories A tiempo completo

**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.

  • Quality Manager

    hace 2 días

    Alajuela, Costa Rica Abbott Laboratories A tiempo completo

    **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...

  • Supplier Quality Manager

    hace 5 días

    Alajuela, Costa Rica Philips A tiempo completo

    **Job Title**: Supplier Quality Manager Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique...

  • Quality Assurance Engineering Manager

    hace 7 días

    Alajuela, Alajuela, Costa Rica Micro Focus A tiempo completo

    Job OverviewMicro Focus is seeking an experienced Quality Assurance Engineering Manager to lead our software quality assurance efforts. This role will be responsible for developing and executing test strategies, plans, and suites for complex products and platforms.Responsibilities- Lead multiple project teams of software quality assurance engineers and...

  • Quality Engineering Manager

    hace 9 horas

    Alajuela, Costa Rica Philips A tiempo completo

    **Job Title**: Quality Engineering ManagerPhilips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation.Driven by the vision of a better tomorrow.But it's not just what we do, it's who we are.We are 80,000, wonderfully unique individuals,...

  • Sr Quality Manager

    hace 2 horas

    Alajuela, Costa Rica Abbott Laboratories A tiempo completo

    MAIN PURPOSE OF ROLE Summarize the main purpose of the role. This position 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. This individual develops and executes the...

  • Key Quality Assurance Manager

    hace 3 días

    Alajuela, Alajuela, Costa Rica Freudenberg Medical Srl. A tiempo completo

    Freudenberg Medical is a leading provider of medical device design and manufacturing services. As a global company, we employ over 50,000 people in 60 countries worldwide.Our focus on innovation drives us to develop cutting-edge technologies and products that improve the lives of people around the world. We take pride in our industry-leading quality, lean...

  • Technical Quality Engineering Manager

    hace 7 días

    Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

    About Abbott LaboratoriesWe are a global healthcare leader that creates breakthrough science to improve people's lives. Our vision is to be the most trusted and respected medical device company.Our commitment to innovation and quality drives us to anticipate changes in medical science and technology, enabling us to deliver solutions that transform patients'...

  • Quality Manager

    hace 9 horas

    Alajuela, Costa Rica Freudenberg Medical Srl. A tiempo completo

    Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations.Together with our partners, customers and the world of science, we develop leading-edge technologies, and excellent products, solutions and services for 40 market segments.The Freudenberg Group employs some 50,000 people in 60...

  • Quality And Compliance Manager

    hace 9 horas

    Alajuela, Costa Rica Abbott Laboratories A tiempo completo

    **_MAIN PURPOSE OF ROLE_**This position provides leadership and guidance for the Quality Assurance and Compliance supporting function at Abbott Vascular Costa Rica.Responsible for developing functional goals objectives, procedures, policies, and systems that are in line with the company objectives, quality policy, regulatory standards, and applicable...

  • Strategic Quality Assurance Manager

    hace 5 días

    Alajuela, Alajuela, Costa Rica 3M A tiempo completo

    **Company Overview**At 3M, we offer a unique work environment that allows employees to thrive in their careers while also having the flexibility to choose how and when they work.Our approach to flexibility is called Work Your Way, which puts employees first and drives well-being in ways that enable our business and performance goals.**Job Description**We are...

  • Senior Quality Assurance Manager for Medical Devices

    hace 3 días

    Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

    About Abbott LaboratoriesAbbott Laboratories is a leading global healthcare company, dedicated to creating innovative solutions that improve people's lives.We are committed to staying at the forefront of medical science and technology, anticipating changes and opportunities in our industry.Join Our TeamAt Abbott Laboratories, you will have the opportunity to...

  • Quality Assurance Manager

    hace 2 días

    Alajuela, Alajuela, Costa Rica Philips A tiempo completo

    **About Philips**We are a leading health technology company committed to improving lives worldwide. Our vision is to create a healthier and more sustainable world through innovation.As part of our team, you will be working towards creating a better future for all. We strive to deliver meaningful solutions that make a real difference in people's lives.**In...

  • Quality Assurance Program Manager

    hace 3 días

    Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

    About AbbottAs a global healthcare leader, we strive to create breakthrough science to improve people's health. Our vision is to anticipate changes in medical science and technology, shaping the future of healthcare.We are committed to making a meaningful difference in people's lives by delivering high-quality products and services that meet their needs. Our...

  • Industrial Operations Manager

    hace 19 horas

    Alajuela, Alajuela, Costa Rica Medtronic A tiempo completo

    About the RoleWe are seeking a skilled Industrial Operations Manager - Quality and Innovation to join our team. This is a dynamic opportunity for an experienced professional who can lead cross-functional teams in the development and implementation of activities to meet production goals, quality, and cost objectives.Key ResponsibilitiesPrioritize production...

  • Lead Customer Service Manager for Quality Improvement

    hace 7 días

    Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

    About AbbottAbbott is a global healthcare leader at the forefront of medical innovation, driven by a passion to improve people's lives. Our company has been a pioneer in the development of groundbreaking technologies that have transformed the healthcare landscape.We're always looking towards the future, anticipating changes in medical science and technology....

  • Quality Manager Iii

    hace 9 horas

    Alajuela, Costa Rica Tec Talent A tiempo completo

    **Knowledge / Education**- Minimum education required to perform duties: Bachelor degree in Engineering or Science (such as Pharmacy, Microbiology, Physics and Chemistry).- Bilingual English/Spanish - Advanced English level (written and spoken).- Knowledge of applicable regulations for the medical device industry (FDA, ISO, other.)- Knowledge of process...

  • Lead Quality Assurance Specialist

    hace 7 días

    Alajuela, Alajuela, Costa Rica Ecolab A tiempo completo

    **Company Overview**Ecolab is a global leader in water, hygiene and energy technologies. We deliver comprehensive solutions, data-driven insights and on-site service to promote healthy environments.At Ecolab, we believe the best teams are diverse and inclusive. We are committed to fair and equal treatment of associates and applicants.**Job Summary**We seek a...

  • Quality Director- Costa Rica Site Quality Leader

    hace 3 días

    Alajuela, Costa Rica Philips A tiempo completo

    **Job Title**: Quality Director - Costa Rica Site Quality Leader Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But it’s not just what we do, it’s who we are. We are 80,000,...

  • Quality Director

    hace 9 horas

    Alajuela, Costa Rica Philips A tiempo completo

    **Job Title**: Quality DirectorPhilips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation.Driven by the vision of a better tomorrow.But it's not just what we do, it's who we are.We are 80,000, wonderfully unique individuals, with two...

  • Quality Assurance Manager

    hace 2 días

    Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

    About Abbott LaboratoriesAt Abbott, we're committed to delivering breakthrough science that improves people's health. Our company is a global leader in healthcare, driven by innovation and a passion for making a difference.What We OfferWe offer a dynamic work environment with opportunities to grow and learn. You'll have access to:Career development with an...