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.

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.

We currently have a role based at our Lake Forest, IL location for a QA/RA PROJECT MANAGER OPERATIONS.  You will , among other responsibilities, serve as a Key Divisional SME for Medical Device Quality Management Systems, ideally with specialist knowledge and experience of Software as a Medical Device, Software in a Medical Device and Mobile Medical Applications.

• Supports the ARDx QARA team and the ARDX business in supporting the analysis, design, development, verification and validation of ARDx global regulated software applications.
• Has global responsibility for evaluating, selecting and introducing new strategic SLC methodologies and technologies, with a main focus on compliance with regulatory expectations.
• Calls for defining, harmonizing and implementing value-added risk-based validation strategies to optimize the efficiency and effectiveness of associated business processes within ARDx and across Abbott in order to improve the business processes of ARDx and Abbott.
• Responsible for implementing and maintaining the effectiveness of the quality system. Manages projects to resolve business issues. Develops timelines, metrics, and benchmarks. Obtains approval for funding and resources, and drives project to implementation.

The ideal candidate should be an experienced project manager with a track record of managing projects with global impact and a dispersed project team.

WHAT YOU’LL DO

• Comprehensive knowledge of Medical Device Quality Management Systems, ideally with specialist knowledge and experience of Software as a Medical Device, Software in a Medical Device and Mobile Medical Applications

• Uses excellent interpersonal and communication skills; negotiates project outcomes, timetables, resources, and other project deliverables.Identifies training requirements and oversees training activities. Recognized by peers, management and clients for project management skills.

• Leads large, diverse (e.g. cross-function, multi-site, international) project teams consisting of 5-15 technical and business users, and acts as a consultant to the less experienced.

• Interfaces with division business systems managers/directors, end user department managers, client general managers, directors, V.P.'s.

• Reaches for senior division management for direction on business issues.May function as the project contact and negotiate with organizations outside of Abbott.

• Supports Division and BU’s as QARA digital and eService SME.

• Ensures continuous improvement and gives input related to QARA for digital and eServices

• Coordinates the introduction of new strategic methodologies; supports and approves the overall validation of global regulated applications

• Defends the validation strategies to internal auditors, regulatory authorities and other certified bodies

• Tracks and reports progress of assigned projects through available tracking tools.

• Collaborates with division and BU leaders to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are met.

• Must be familiar with Quality Risk Management principles and practices and guide teams and management with risk-based decision-making capabilities.

• Must be familiar with Good Documentation Practices and assist as appropriate with required documentation for compliance purposes.

 EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Master degree and/or Bachelor’s degree with commensurate real world experience
• Minimum 10 years of project management experience (preferred areas below)

Preferred

• MBA degree
• Prior and/or current experiences In medical/biotech industries. 
• Knowledge of regulations and standards of medical devices.
• 5-10 plus years of service industry experience with companies engaged in the manufacture of high quality, FDA regulated products.

• Proven leadership skills, results oriented, highly collaborative, team player, and self-starter who can operate in a fast pace environment.
• Experience in state-of-the-art, multi-step, high volume, process control servicing and process development. Experience with ISO 9001/CE Mark requirements.
• Management experience in service planning and delivery, documented systems, GMP, and quality.

 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.