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

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 Division

Quality Manager, Laboratory Services.

WHAT YOU’LL DO

 The Division Quality Manager, Laboratory Services is chiefly responsible for providing subject matter expertise, guidance and support to ARDx entities providing laboratory and service functions, the development of Division policies/procedures related to laboratory and service provision, and, where applicable, establishing Division-level processes to enable ARDx commercial organizations to support customers in achieving laboratory accreditation.

The role provides subject matter expertise and hands-on support to ARDx Business Units (BU) and their sites in the appropriate application of Abbott policies to laboratory and service functions including the development of BU/site level standard operating procedures and eSystems that implement applicable Abbott polices and ensure achievement and/or maintenance of needed quality accreditations and certifications such as, but not limited to CLIA, SAMHSA, ISO17025. This includes the responsibility for global oversight, monitoring and continuous improvement of the ARDx laboratory and service provision, policies and processes. This will be achieved in conjunction with the BU and site leadership through the development of standardized laboratory and service provision metrics and the mechanisms for gathering and reporting these metrics.

The Division Quality Manager, Laboratory Services works closely with Business Unit leaders and ARDx entities globally to ensure Division program deliverables are well communicated and aligned to business priorities. The role will be office or laboratory based with travel expected, when necessary.

RESPONSIBILITIES

• Develop and maintain Divisional policies, processes and procedures pertaining to laboratory and other service provision consistent with Abbott policies and appropriate accreditation body requirements.

• Work with ARDx Business Units that perform laboratory testing as a service to develop, maintain and improve quality system structures necessary to achieve and maintain accreditation to the various laboratory accreditation bodies, including, but not limited to CLIA, SAMHSA, ISO17025.

• Collaborate with the Divisional audit team to support audits of laboratory and consumer service entities, including creation of Division-level laboratory and consumer service audit checklists to assist in audit conduct and monitoring of continued compliance.

• Provide leadership and support to projects, as defined by BU/Division leadership, that are critical to the business or improve the general compliance in laboratory testing and other consumer services.

• Communicate across the Division to ensure best practices in laboratory services are shared.

• Develop a strategy to support the commercial teams in the provision of documentation and services that will result in the successful accreditation of customers in countries where laboratory accreditation is mandated.

• Provide leadership in the development and maintenance of standardized metrics for laboratory services, including mechanisms for gathering and reporting required data.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Minimum of a Bachelors’ degree in a science related field  
• Minimum 7 years’ working within quality in a laboratory or medical device regulated environment
• Highly proficient in ISO17025 and experienced in implementation of laboratory quality management systems to achieve ISO17025 accreditation. Similar experience in ISO13485, FDA medical device, laboratory CLIA or CAP regulations desirable.
• Experienced in performing internal audits and hosting external accreditation audits.
• Experienced in working as part of a multi-national Quality Management System team.
• Experienced in data flow and data integrity requirements.
• Thrives under pressure and able to handle complex problems and organizational structures.
• Strong written and verbal communication skills with ability to communicate effectively to a wide audience, including subordinates, peers and superiors.
• Receptive to working in a fast-paced, ever-changing work environment that values those capable of stepping out of their comfort zone on a day to day basis.
• Able to influence data-driven decisions that appropriately balance business needs with regulatory requirements, ensuring compliant outcomes that also meet business needs.
• Works collaboratively with others and able to navigate cultural differences at the global level.
• Implementation of a medical device quality system, compliant to ISO13485 and/or 21 CFR 820.
• Working knowledge of Joint Commission requirements would be a distinct advantage
• Experience in using Electronic QMS technologies
• Strong technology awareness in line with technologies in use across the Division (e.g. MS Office, MS Visio, SharePoint)
• Certified Lead Auditor and/or laboratory or Joint Commission auditing experience
• Understanding of Six Sigma/LEAN practice

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.

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