Director, Global Product Quality Assurance

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 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Job Title
Director, Global PQA
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 student debt program and FreeU 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 Abbott Park, IL location in the Core Diagnostics 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, Global Product Quality Assurance directs and coordinates the on-market Quality Assurance activities for complaint handling, risk management and product monitoring for the Abbott Diagnostics Division. Responsibilities include ensuring assigned Quality System responsibilities are completed efficiently and support outputs that improve customer satisfaction while maintaining compliance. Responsibilities include advising senior management regarding action plans for critical events related to Product Quality and product safety. The position also has direct interface and activity/strategy coordination with leadership teams in Global manufacturing, Commercial, Regulatory Affairs and Legal and extends to external business partners (TPMs) and regulators.
What You'll Work On

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Develop the Product Quality strategy to achieve business objectives while ensuring compliance with global regulatory requirements, making key decisions on Product Quality issues.
• Assure line of communication with DVP Quality Assurance and Senior Leaders on critical quality issues.
• Lead the Division Product Quality Assurance organization.
• Assure business continuity in leadership positions and critical roles through talent management planning and development.
• Create a diverse organization and encourage diversity within the organization.
• Direct and implement programs across the Division to ensure improved customer satisfaction and compliance with regulatory requirements.
• Monitor customer complaint trends, identifies, communicates and addresses adverse trends that may impact the business / customer.
• Provide feedback into product improvement initiatives using customer data.
• Provide oversight to disposition high-risk product non-conformance situations, assure adequate investigation and corrective actions are in place to prevent future occurrences.
• Support cost controls for PQA staff.
• Authorizes cost efficiency projects that contributes to Division margin improvement initiatives.
• Directly responsible with interface with outside regulators (FDA, Ministries of Health, Notified Bodies) and other government regulatory bodies.

Required Qualifications

• Bachelor's Degree in a scientific or technical field or an equivalent combination of education and work experience.
• Minimum 6 years in the Medical Device Industry or other FDA regulated industry, including a role in a Quality/Compliance discipline while holding positions of leadership responsibility.

* 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
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 salary for this role is between:
N/A
JOB FAMILY:
Operations Quality
DIVISION:
ATM Transfusion
LOCATION:
United States > Abbott Park : AP52
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf