Quality Systems
hace 4 semanas
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre 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 â Alajuela location in the Electrophysiology Division. In Abbottâs Electrophysiology (EP) business, weâre 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 Systems & Compliance Engineer IV, you will be responsible to integrate and maintain quality systems in Costa Rica in accordance with all applicable regulations, standards and Abbott/AQ policies. This includes but no limited to proactive implementation and maintenance of compliance of the divisional quality system and site specific procedures and practices, search and appliance of integration initiatives and improvements. This role is intended to work independently on the leadership within Costa Rica for all-across application of the system and may have supervision responsibilities of direct reports within quality systems organization.
What Youâll Do
- Provide Quality System Body of Knowledge support to the organization.
- Lead cross functional teams to execute Quality System initiatives.
- As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member).
- Draft, review, and update Quality Systems support documentation to proactively comply with applicable internal, domestic, and international standards or regulations.
- Support and execute internal/external Quality System audits.
- Ensure compliance to all Quality System Regulations and policies applicable to business units in Costa Rica by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements.
- Identify opportunities for improvement regarding compliance to all Quality System Regulations and policies applicable to business units in Costa Rica.
- Support, executes and resolves investigations related either to non-conformances or improvement opportunities.
- Work with the organization during new product introductions to ensure quality deliverables such as Quality Plans and Risk Management are in place for the products being transferred.
Required Qualifications
- Bachelor´s Degree in Engineering, Business Administration, or Science
- At least 5 years of total experience:
- 2+ years in Quality Systems, Compliance positions, or demonstrated equivalent experience in Quality.
- 2+ years of experience in an FDA (QSR), ISO 13485 or ISO 9001 controlled industry.
- Experience in CAPA process: investigation, resolution, implementation, verification of effectiveness and mentoring and support to CAPA system (CATSWeb and EPIQ) and CAPA owner.
- Demonstrated knowledge of quality systems including but not limited to Training, Documentation, Microbiology, Testing and/or Quality Release.
- Demonstrated experience in Quality, Engineering or work within structured processes, desirable in Medical Devices.
- Exposure and application of regulations for Medical Devices (FDA-QSR, ISO13485) or experience in ISO9001.
- Knowledge and Application of process improvement such as: (Root Cause Analysis, Fishbone, Is/Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).
- Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
- Advance command of English.
- Shift Admin
Preferred Qualifications
- Quality Auditor training for ISO 13485 or 9001
- Certified Quality Engineer.
- Quality Systems related certifications (Quality Control, CAPA, Risk Management, etc).
- Masters (in progress or completed) on Quality Management, Operational Excellence, Project Management or similar.
- 1-2 years of experience participating on ISO and/or FDA audits is a plus.
Apply Now
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
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