CAPA Program Manager

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Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

At Abbott Molecular, we realize the potential of personalized care as the laboratory's most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics.

Abbott Molecular Our Des Plaines, IL site has an opportunity for Molecular Diagnostics CAPA Program Manager

WHAT YOU WILL DO:

• Incumbent is responsible for implementing and progressively improving the CAPA process and electronic system within the Quality Management System at Abbott Molecular.
• Incumbent is responsible for the design, performance, and governance of the Corrective Action and Preventive Action (CAPA) program within Abbott Molecular, which includes:
  • Quality System Procedures
  • IT Solution (ABTRAQ)
  • User Awareness and Competency including training
  • First Time Right performance
    Key Performance Indicators (KPIs)
• Frontline auditor interface
• CAPA Review Board Member and QA Approver

Background:

• Proven progressive thinker who has significantly improved QMS's, particularly the CAPA process
• Strong working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485: 2016
• Strong people leadership skills and ability to influence others without direct authority
• Strong interpersonal and collaboration skills - collaborates across boundaries to create process
• Strong working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485: 2016
• Strong people leadership skills and ability to influence others without direct authority
• Strong interpersonal and collaboration skills - collaborates across boundaries to create critical thinker
• Displays positive energy/ attitude and persistence to drive organization forward
• Delivers on commitments - takes accountability for failure
• Customer focused
• Business minded
• Addresses organizational or cultural barriers that could prevent success
• Proven project management skills and success
• Experience with frontline auditor interface
• EDUCATION AND EXPERIENCE, YOU'LL BRING:

Required:

:

• 4-year degree in a scientific or technical discipline
• Minimum 5 years of Quality Management System (QMS) management experience in the medical device industry
• Minimum 5 years of people/talent management experience
• Minimum of 5 years of FDA experience, including participation in device inspections.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority (Include for Manufacturing roles only)
• Production areas that are clean, well-lit and temperature-controlled (Include for Manufacturing roles only)
• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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