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.

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

Working with the Commercial Quality Assurance group to provide support and guidance regarding:

• Strategic direction as well as technical support for Commercial QA managers and associated Affiliates and Distribution.

• Metrics and Measurement for elevation to Division QA.

• Develop and maintain Affiliate appropriate Quality Systems that ensure the Affiliates conform to relevant legislation and Abbott Quality Standards.

• Provide technical resource regarding Quality Systems and compliance. Specifically in regards with EU medical device and in vitro diagnostic (IVD) (EU Regulation 2017/745 and EU Regulation 2017/746) Economic Operators who act as importers and/or distributors for ADC products.

• Monitor changes in the supply chain in regards with product distribution and evaluate the impact in regards with Economic Operators to ensure compliance with EU medical device and in vitro diagnostic regulations.

• Interact with Operations, Supply chain, Quality, Regulatory and Commercial Affiliates to ensure compliance with EU medical device (MDR) and in vitro diagnostic (IVDR) (EU Regulation 2017/745 and EU Regulation 2017/746) Economic Operators for ADC products.

What You'll Work On

• Define, develop and deploy an appropriate Affiliate Quality System.

• Support the Affiliates with the maintenance of the quality system to meet the requirements of ISO 13485 and EU medical device and in vitro diagnostic (IVD) (EU Regulation 2017/745 and EU Regulation 2017/746).

• Maintain and develop positive relationships with Commercial Affiliates, Quality, Regulatory, Operation, and Supply Chain to positively influence decision-making and ensure conformity to international regulations including ISO 13485 and EU medical device (MDR) and in vitro diagnostic (IVDR). Integrate key initiatives into commercial sites as appropriate, based on compliance risk and availability of resources and business processes to support.

• Build training programs and oversee roll out to ensure compliance with identified quality/regulatory goals and standards.

• Work with Area Commercial QA Managers to coordinate inspection readiness programs across all Affiliates.

• Represent Commercial QA in cross-functional projects, working with other functions including pharmacovigilance, regulatory, commercial to develop and implement cost effective market compliance programs.

• Promote sound, quality principles to support quality systems compliance at Commercial Affiliates while minimizing cost increases and potential disruptions to business.

• Provide input to the Division Management Review process as required for Commercial activities at Affiliates.

• Provide back up support as required for other functions within Commercial Quality group.

• Develop and manage Quality Agreements between ADC Division and Commercial Affiliates.

• Ensure consistent application of relevant Quality Assurance policies, programs, and systems by clearly defining specific Abbott, ADC SOPs, and locally developed procedures that govern critical to success business functions.

• Perform or support internal ADC Affiliate audits and support preparation of Corporate / Divisional Audits at Affiliates; serve also as first-hand aid in resolving Affiliate QS related issues.

• Work within region to assist Affiliates in audit responses and appropriate corrective actions. Review Affiliate audits and respond in a regional manner, assuring any similar deficiencies at other Affiliates are also addressed.

• Work with ADC Division to support global initiatives as they relate to the Commercial Quality organization.

• Support management to ensure effective operation of the business while maintaining compliance with policies, procedures, and legal and regulatory requirements.

Required Qualifications

• Bachelor’s Degree in Life Science; Engineering; or closely related discipline.

• Minimum of 5 years in Quality or related field experience; Less experience may be appropriate with advanced degree. Preferred experience in the Healthcare industry.

• Has a history of completing successful projects and driving positive compliance outcomes.

Preferred Qualifications

• High familiarity with IVD / Medical Device Quality Systems & respective requirements.

• Understanding of ISO 13485 and/or ISO 9001 requirements.

• Quality Certification as CQE, CQA, CQM via ASQ. ISO 13485 auditor training / certificate.

• Experience with working in international environment/projects.

• High cultural sensibility.

• Strong, well developed interpersonal, communication and negotiation, and good project management skills.

• Proficient use of various software applications such as Microsoft Word, Excel, and Access.

• Ability to travel up to about 15% of the time.

Apply Now (https://www.jobs.abbott/us/en)

• 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 $95,500.00 – $190,900.00. 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