CAPA Manager

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 113,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

About Abbott

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.

Abbott's life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. 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 Rapid Dx North America, LLC's Orlando site is part of Global Business Services (GBS) within the Abbott Rapid Diagnostics (ARDx) Division. GBS has a global accountability to deliver an excellent customer experience and create business value through compliance, standardization and data analytics. GBS also designs and develops Software products for ARDx businesses. The GBS group fosters a collaborative, team focused and winning environment where employees are accountable and encouraged to develop themselves.

WHAT YOU'LL DO

The CAPA Manager provides leadership to the progression of CAPA investigations and to other activities of the CAPA Program. Leads and coaches cross-functional teams in the use of investigational tools to determine the root cause of nonconformities, ensures that CAPA plans address root causes, and that CA/PAs are implemented timely to facilitate the rapid and compliant introduction of new/improved products, processes, and systems. Is an effective leader of multifunctional teams, in many occasions highly technical, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct and that the result of investigations and root cause analysis are technically sound and compliant with FDA and International regulations.

Duties and Responsibilities

• Evaluate and progress the timely completion of CAPA system activities, including effectiveness checks, raised for nonconformances, potential non-conformances, CAPAs, deviations, and/or complaint investigations, as output from ARDx Quality System.
• Provides operational leadership to the CAPA organization and to multifunctional teams composed of technical subject matter experts involved in the resolution of quality issues and continuous improvement of the quality system.
• 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.
• Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled in ARDx Quality System.
• Must be able to communicate the work and decision-making process of investigations to a professional staff of engineers, scientists and to higher level management (DVPs, Directors & Managers).
• Provides subject matter expertise on the CAPA process during internal and external inspections.
• Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
• Represents the ARDx CAPA organization on Interdivisional committees and Communities of Practice to drive continues improvement across the corporation.
• Influence and visibility extend beyond immediate organization and grade level, including international sites, ARDx & Corporate and Divisional Management across Abbott.
• Position involves interactions across multiple functional areas including Technical Services, Customer Service, Marketing, Supply Chain, Quality and Regulatory.
• Accountable to the Quality Organization for achieving mutually agreed upon objectives.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Carries out duties in compliance with established business policies and procedures.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Compile and institute quality metrics to present at review meetings to trend, recommend, and implement corrective actions and appropriate follow-up, when necessary.
• Perform other duties and projects as assigned.

WHAT YOU'LL BRING

Required:

• Bachelor's Degree in technical or life sciences and 5+ years' experience in working in a regulated environment or equivalent combination of education and work experience.
• Working knowledge of investigational and Root Cause Analysis Techniques.
• Ability to apply strategic, quality logic and excellent project management skills to investigation activities.
• Good working knowledge of FDA Quality System Regulations (QSR) and/or ISO13485.
• Able to independently determine and develop an approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives.
• Must have strong organizational, interpersonal, written and verbal communication skills.
• Must be self-directed, adept at juggling multiple projects and comfortable in a fast-paced and ever-changing work environment.
• Must be proficient in MS Outlook, Word, Excel and data reporting, trending and analysis.

Preferred

• Experience in healthcare regulated industry (Med Device, IVD, biotech/Pharmaceutical)

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: 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, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

JOB FAMILY:
Operations Quality

DIVISION:
IDDM ARDx Infectious Disease Developed Markets

LOCATION:
United States > Orlando : 30 S. Keller Road

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 5 % of the Time

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf