Principal Quality Professional, Supplier Quality (Strategic Projects - Reagents)

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

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.

We currently have an opportunity for a Principal Quality Professional, Supplier Quality (Strategic Projects- Reagents) that can be located in either Lake Forest, IL, Irving Texas or Sligo, Ireland. This team member will develop and deliver Supplier Quality process improvement initiatives and act as a key representative for the Supplier Quality organization working on Division projects. Specifically, the individual will play a lead role in Supplier Quality tasks associated with achieving TPM product compliance to the new EU IVD Regulation (IVDR). Additionally, this person will execute tasks and play a leadership role by partnering across business functions to develop effective, compliant solutions. 

WHAT YOU’LL DO

• Responsible for implementing, and maintaining the quality system including the quality policy, the quality plan, and the organizational structure to support the quality system.  Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes.
• Works with suppliers and internal stakeholders to ensure products continue to be safe and effective.
• Manages Third-Party Manufacturer (TPM) inputs and outputs associated with the IVDR Program e.g. change notifications, quality agreements, Design document approval, DMR approvals. 
• Collaborates with Supplier Quality and Global Cross Functional Teams to develop solutions to quality process inefficiencies, compliance gaps and create new business tactics.
• Functions well within a Global matrix organization.  Uses metrics to measure performance.  Recognizes risk relative to product issues and takes appropriate actions while maintaining compliance to processes and procedures including use of Risk Management tools. 
• Uses Project Management tools and methodologies to translate top-level project goals to specific project tasks, milestones and deliverables, and manages the plan to deliver projects consistently.
• Has excellent problem-solving skills and makes timely decisions while considering the facts and data at hand.
• Possesses strong communication skills and can adjust style to respective audience (managers, peers, customers, suppliers, executives, etc.).  Garners support from and manages key stakeholders to enable successful project outcomes including resource allocation negotiation. Establishes and cultivates an extensive network of support to facilitate completion of assignments.
• Makes independent decisions within broad parameters while assuring that these decisions are compliant with division level policies and procedures and are aligned with the regulations and corporate procedures. Elevates risk to manager when appropriate, highlighting issues and presents possible solutions.  Takes personal responsibility to resolve issues.
• Provides innovative solutions to a wide range of difficult problems.  Directly influences project direction and scope.
• Champions new initiatives and acts as the catalyst for change within and potentially across divisions. 

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Knowledge of regulations and standards affecting IVDs and Biologics. 
• Bachelor's Degree preferably in a technical discipline, with eight years’ experience or direct relevant experience sufficient to demonstrate the knowledge typically associated with the degree and experience required.    Less experience may be appropriate with advanced degree.
• Experience in the health care industry.
• Experienced in customer utility of diagnostic products.   
• Advanced experience with project management and has a history of completing successful cross-functional projects and driving positive compliance outcomes. 

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

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.

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

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