02 feb
Abbott Laboratories
Ciudad de México
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 Queretaro site in Mexico in the EP 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.
The Sr. Quality Engineer works closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators. The role also involves leading process/product validation activities, working with Research and Development and Regulatory Affairs personnel to assure compliance with product and regulatory requirements, and owning major quality system investigations and audits.
What You’ll Do
1. Verify company’s adherence to the established Quality System and GMP/ISO standards.
2. Complete risk management and risk analysis including FMEA, providing mentorship to lower-level engineering positions.
3.
Work with R&D;/Design Quality to revise design verification and validation plans based on performance specifications and risk analysis.
4. Support technical and statistical investigations concerning optimization and compliance to specification.
5. Own measuring process capability, process controls, and process validation efforts.
6. Collaborate with microbiology to ensure appropriate environmental monitoring.
7. Conduct and own NCMR Investigations, CAPAs, Calibration Out Of Tolerance (OOT) Investigations, and Complaint Investigations.
8. Document Monthly Quality Data Review, providing data analysis and escalation recommendations.
9. Lead and own Build At Risk (BAR) Authorizations & Closures.
10. Complete and approve document Change Requests for compliance.
11. Create and maintain Quality Plans and Reports.
12. Own, execute,
and author IQ, OQ, PQ, and/or PPQ Qualifications.
13. Conduct advanced statistical data analyses using Minitab.
14. Create and author Master Validation Plans and Reports.
15. Support activities during audits, functioning as SME for specific Quality activities.
16. Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
17. Lead, coach, and mentor non-exempt and entry-level exempt personnel.
18. Communicate details and information of events related to quality to upper management.
19. Lead management meetings such as QDR, KPIs, and Management Review.
20. Perform other duties and responsibilities as assigned by senior management.
21. Perform supervisory activities to Quality Technicians or Quality Engineers, if required.
Required Qualifications
- Education:
STEM (Science, Technology, Engineering (preferred), Math) with equivalent experience in medical devices or pharmaceutical quality control.
- Bachelor's Degree (University Level).
- Experience: 5 years experience in Quality Engineering positions, with preferably 3+ years in quality engineering roles.
- Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
- Knowledge of statistical/data analysis and report writing experience.
- Experience with control of nonconforming material, corrective and preventive actions.
- Experience in process improvement tools such as Root Cause Analysis, Six Sigma, or Process Control & Monitoring (SPC).
- Detailed knowledge of FDA, GMP, and ISO 13485.
- Experience on product and process qualification and transfer.
- Project management experience,
participating or leading multi-departmental project teams.
- Experience on External and Internal audits.
- Experience mentoring lower-level engineering positions on Technical Writing.
Language Proficiency
Advanced command of English required, including fluent oral and written communication.
Preferred Qualifications & Education
- Experience with SAP.
- ASQ CQE / Six Sigma Blackbelt or similar certification.
- Participation or leading multi-departmental project teams.
- Experience in a supervisory role.
- Master's Degree in a related field.
- ISO 13485 certification as Lead Auditor or similar.
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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