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Sr. Quality Risk Management Specialist


This is a Contract position in Irving, TX posted June 12, 2019.


Quality Risk Management SpecialistAt Abbott, we’re committed to helping people live their best possible life through the power of health.

For more than 125 years, we’ve brought new products and technologies to the world in nutrition, diagnostics, medical devices and branded generic pharmaceuticals that create more possibilities for more people at all stages of life.

Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.JOB DESCRIPTION: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 103,000 colleagues serve people in more than 160 countries.Job Description:Main Purpose of Role:(Newly-created, full-time position)Seeking a Sr.

Quality Risk Management Specialist (formerly titled Sr.

Risk Management Analyst) to join the Dallas Quality organization.

This position serves as a subject matter expert and resource within risk management discipline; technical expert on functional or cross-functional teams and projects.

Additional Main Responsibilities:Execute and support on-time completion of Risk Management Deliverables.

Ability to support highly complex or specialized projectsMaintain Risk Management deliverables to ensure continued acceptability of product based on post market feedbackSupport Risk Management / Cybersecurity activities from product Concept through product obsolescence.

Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gapsEnsure verification and validation evidence supports the planned risk mitigation strategyMentor engineers and Quality on risk management within the quality organizationProven ability to effectively lead cross-functional teams with respect to risk management activities and to influence where direct reporting line relationships do not exist.Complies 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 Education, Experience, etc.: Bachelor’s Degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.

Experience in medical devices or other highly regulated industry2 years Safety, Product or Systems Engineering experience2 years of Risk Management (specifically ISO 14971)Experience working in or with Design, Quality and OperationsWorking knowledge of statistical methods, design history file contents and evidence, and risk management practicesPreferred (Optional) Experience, etc.:2 () years risk management experience from medical device (e.g.

blood screening instrument) and/or pharmaceutical company.Experience with both ISO 14971 and 13485Risk Management CertificationJOB FAMILY:Operations QualityDIVISION:ADD DiagnosticsLOCATION:United States > Irving : LC-02ADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 5 % of the TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT 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: is the Law link
– Espanol: is about the power of health.

For more than 125 years,Abbott has been helping people reach their potential — because better health allows people and communities to achieve more.

With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life.

Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people.

They push the boundaries to help manage and treat some of life’s greatest health challenges.We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.Follow Us:FacebookLinkedInYouTubeTwitter