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Abbott CAPA Manager in Abbott Park, Illinois

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 107,000 colleagues serve people in more than 160 countries

About Abbott Diagnostics

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Our location in Lake Forest, IL currently has an opportunity for a CAPA Manager. This position is responsible for developing, establishing and maintaining CAPA subsystem, policies, processes, procedures, training materials and controls enhancing the performance and quality of products and the divisional capability to demonstrate conformance to established standards and agency regulations.

WHAT YOU’LL DO

  • Provide expert level guidance and direction of the CAPA systems Body-of-Knowledge.

  • Provides subject matter expertise, leadership and training on investigational & Root Cause Analysis techniques, as appropriate, to other CAPA team members and to technical subject matter experts involved in the resolution of quality issues

  • Represent Quality Systems as required in support of cross-functional divisional projects. Identify Quality Initiatives and lead cross-functional teams to complete them

  • Provide influential leadership with International sites to drive proactive quality system improvements.

  • Provide diligent and fact-based communication to Executive Management team, peers, and team on Quality Systems initiatives and changes.

  • Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.

  • Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.

  • Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.

  • Produce and analyses trend metrics and reports and establishes further actions, as may be required.

  • Represents the ADD CAPA organization on Interdivisional committees and Communities of Practice to drive continues improvement across the corporation.

  • This position will serve as a functional representative for organizational initiatives potentially impacting or affecting the QMS.

  • Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.

  • Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment. Provide management and development of the CAPA management staff.

  • Accountable to the Quality Organization for achieving mutually agreed upon objectives.

  • Influence and visibility extend beyond immediate organization and grade level, including international sites, ADD & Corporate and Divisional Management across Abbott.

  • Position involves interactions across multiple functional areas including operations, R&D, Marketing, Supply Chain, Quality and Regulatory.

  • Compliance activities are of the utmost importance to our business.

  • The CAPA System is a key inspection focus of worldwide regulators and auditors.

  • The system must be usable, simple, sustainable and well maintained; Failure to comply with the primary objectives of this role can result in negative impact to the business such as observations, warning letters, de-certification, or product recalls.

  • Decisions and recommendations made by this position directly influence and impact the quality of marketed products and the effectiveness of ADD’s Quality System to applicable regulations.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

  • Bachelor's Degree preferably in a technical/scientific discipline e.g., Chemical, Physical or Biological Sciences, Pharmacy, Microbiology, Medical Technology, Engineering

  • Minimum of eight years’ experience in a Quality or Technical area, including two years of direct supervisory experience. Experience should include quality, technical product support and /or development, budgetary responsibility, and functioning in a matrix-managed environment.

  • Knowledge of regulations and standards affecting IVDs and Biologics.

Preferred

  • Demonstrated organizational influence to include, but not limited to: compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction.

  • Medical Device manufacturing experience (FDA Class III preferred).

  • Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies

  • Strong project management, team skills, and influential management

  • Experience working in a broader enterprise/cross division business unit model

  • Ability to work in a highly matrixed and geographically diverse business environment.

  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

  • Ability to work effectively within a team in a fast-paced changing environment.

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

  • Multi-tasks, prioritizes and meets deadlines in timely manner.

  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.

  • Ability to travel internationally

WHAT WE OFFER

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

  • 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: www.abbottbenefits.com at http://www.abbottbenefits.com/pages/candidate.aspx

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.

Connect with us at www.abbott.com at http://www.abbott.com/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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