Quality Assurance Specialist

hace 1 semana

Xico, México Abbott Laboratories A tiempo completo

About Abbott Laboratories

Abbott Laboratories 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 Laboratories

At Abbott Laboratories, 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

We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.

Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology.

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

Our rapid diagnostics solutions are helping address some of the world's greatest healthcare challenges.

Job Responsibilities

This position administrates regulatory compliance activities related to the Internal Audit Program. The position is key in the facilitation/execution of the internal inspection process and ensures the Internal Audit Program across the Abbott Diagnostic business Sites/Commercial Affiliate Sites serves to identify Quality System improvements.

Independently conducts assigned audits of Suppliers and Third-Party Manufacturers (TPMs) to assess compliance to all applicable external standards and regulations as well as Abbott Quality System requirements at a standard commensurate with regulatory external audits.

  • Plans and conducts internal audits across the Abbott Diagnostic business Sites/Commercial Affiliate Sites to assess compliance to all applicable External Standards and Regulations as well as Abbott Quality System requirements.
  • Identifies compliance risks to current standards/regulations and may guide in the planning and execution of Quality System improvements.
  • Ensures compliance to Division and Corporate policies and procedures by promptly reporting non-compliance issues.
  • Supports and implements an internal audit schedule for Core Diagnostics manufacturing and commercial affiliate sites.
  • Reports audit findings in a timely manner.
  • May lead projects that are cross-functional in scope, directly influences project direction and scope, champions new initiatives.
  • Maintains and demonstrates understanding of global standards, regulations, and regulatory bodies.

Requirements

  • Bachelor's Degree in Life Science, Engineering, or closely related discipline is required. A non-scientific certification with a minimum of 3 years of Medical Device experience may be considered in lieu of a degree.
  • Knowledge of Good Manufacturing Practices (GMPs), Quality System standards, and regulatory requirements such as 21 CFR 820; ISO 13485; IVDR; etc.
  • Trained in auditing techniques; Certified Auditor qualification or equivalent is required. Excellent written and verbal communication skills.

Working Conditions

The incumbent will report to the Manager; Global Compliance and Auditing and will be a direct staff member. It is expected that the individual will interact with senior management and therefore requires a high level of competence, confidence, and credibility. International travel is expected of up to 60%.

About Abbott Laboratories

Follow your career aspirations to Abbott Laboratories for diverse opportunities with a company that can help you build your future and live your best life. Abbott Laboratories is an Equal Opportunity Employer, committed to employee diversity.

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