JOB DESCRIPTION:
Job Title
Sr Quality Manager – Medical Devices
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 in our manufacturing site in Queretaro, Mexico. With Electrophisiology 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.
MAIN PURPOSE OF 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.
What You’ll Do
- This individual develops and executes the required strategies and plans to improve product and process quality to deliver planned business results and assure compliance with FDA and ISO regulations and any country specific regulation where 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.
- This position may be appointed with the responsibility of Management Representative for the business unit and / or Sanitary Representative.
Required Qualifications
- 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.
- FDA Class II or Class III medical device experience
- 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 & Opex.
- Ability to travel to support domestic and international manufacturing sites (up to 15%).
Qualifications and Education
- Bachelor's degree (4-year degree) Engineering, Science or Technical Field, or Bachelor's degree in Business Administration.
- Master´s degree.
- 8+ 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).
- Opex & Project Management
Language proficiency
- Fully bilingual (English & Spanish) / Required
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
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
EP Electrophysiology
LOCATION:
Mexico > Queretaro : Avenida FINSA 156, Lote 12
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 15 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
