Job Information
Abbott Director, Digital Health Quality in Lake Forest, 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 114,000 colleagues serve people in more than 160 countries.
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of.
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Lake Forest, IL location in the Core Lab Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. The Director, Digital Health Quality will establish and maintain strategies, policies, and processes within the Digital Health area covering a broad range of products including non-medical products, but also products regulated as medical devices. They will play a key strategic role in ensuring the quality system meets the needs of the business as well as any applicable regulatory bodies, and evolves as the digital space evolves. They role will interact with numerous global functions to represent the voice of Quality in key strategic discussions and will have the ability to contribute to outcomes that meet business needs.
What You’ll Work On
Provideglobalstrategicdirectionandtacticalassistancefor the digital health areaand support onmattersrelatedtoregulations, qualitysystemsandqualityissues. This role hasaccountabilityforcomplyingwithlocalandglobal Quality System requirementsas applicable to the product portfolio.
Providedirectiontothe Digital Healthorganizationinthedevelopment, implementationandmaintenanceof a Quality System appropriateforthefunctionsperformed noting that some products supported are not medical devices while others are regulated as so.
Providediligentandfact-basedcommunicationto Management team, Business Unit leaders, peers, andquality, regulatoryandotherfunctionalteammembersintheorganization.Assure Quality providestechnical support andservicesto Engineering, Research & Development andothercross-functionalgroupsinvolvedin developing, launching,andmaintainingdigitalproductsand e-Services delivery.
Support allDivisionalinitiativesasidentifiedby management andin support of Quality Management Systems (QMS), Quality Management reviews, andotherregulatoryrequirementsandprogramsasprioritizedbyleadership.
Work as a memberofthe management teamtodevelopandmonitorqualityobjectives., appropriate Quality KPIs, and provide oversight of Quality processes.
Serveasthe Management Representativeforthe Quality System; actsas a pointofcontactprovidingqualityguidanceandexpertisetorepresentthe Digital Health organization as the main interface with necessary regulatory bodies and external auditors.
Supportdevelopmentof QA personnelthroughinteractionandtrainingtoensurepersonnelareinformed, andthatbusinessinteractionsandprocessescomplytoapplicablelawsandregulations.
Implement Global Standards / Proceduresand e-enterprisesystemsasneededto support thequalitysystem.
Responsibleforexhibitingprofessionalbehaviorwithbothinternal/externalbusinessassociatesthatreflectspositivelyonthecompanyandisconsistentwiththecompany’spoliciesandpractices.
Understand and beawareofthequalityconsequencesthat may occurfromtheimproperperformanceoftheirspecificjob. Have awarenessof potential defectsthat may occurintheirareaofresponsibility, andacrossthebusinessprocessesoftheorganization; includingproductdesign, verificationandvalidation, manufacturingandtestingactivities.
Accountableforestablishingappropriatetrainingfortheorganization, including QS trainingandensuringrequirementsofapplicableregulationsareencompassedinlocalprocedures.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Required Qualifications
Bachelor's Degree in related field, or an equivalent combination of education and work experience.
Minimum of 10 years related work experience.
Experience leading teams across functions and managing in a matrixed environment. Experience leading across geographically diverse environment.
Demonstrated strong leadership skills and ability to influence decisions. Demonstrated ability to communicate effectively both verbally and written.
Ability to travel up to 25%, including internationally
Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies.
Preferred Qualifications
B.S/B.A.in Software Engineering/Development, Engineering, Technical Discipline or Science. Master's degree preferred.
10+ years combined experience in science/engineering/technical industry.
3 plus years management experience.
5 + years in Quality or Software Development/Engineering.
Experience in development of products (software and apps preferred) including knowledge of agile design processes and best practices.
Experience with industry best practices for software development/management.
Experience with complex problems requiring critical thinking. Experience interacting with Sr. level management.
Work experience in quality desired with at least 3+ years management of demonstrated compliance excellence, value improvement, risk reduction, and cost containment. Class III or II medical device background.
Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.
The base pay for this position is $143,300.00 – $286,700.00. In specific locations, the pay range may vary from the range posted.
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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