Senior Quality Systems Engineer

Abbott Laboratories Plano , TX 75023

Posted 1 week ago

At 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:

The Senior Quality Systems Engineer has overall site responsibility for developing, establishing and maintaining quality systems programs, policies, processes, procedures, training materials, and controls. This position will enhance the performance and quality of our products and our capability to demonstrate conformance to established standards and agency regulations. Further, this position will work globally to create best-in-class harmonized quality systems procedures across Abbott sites.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Impact this role will have on Abbott:

  • Provide overall Quality Systems leadership for including:

  • Provide expert level guidance and direction of the Quality Systems Body-of-Knowledge .

  • Aggressively identify opportunities to apply, continuously improve, and redefine quality systems and controls for all divisional product-related processes in accordance with applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.

  • Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.

  • Support efforts in creating best in class Quality System procedures across Abbott sites

  • Ensure Quality Systems are compliant with changing regulatory environment (including standards)

  • Represent Quality Systems as required in support of cross-functional divisional projects.

  • Identify Quality Initiatives and lead cross-functional teams to complete them.

  • Provide diligent and fact-based communication to Management team, peers, and team on Quality Systems initiatives and changes.

  • Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.

  • Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization.

  • This position will serve as a functional representative for organizational initiatives potentially impacting or affecting the QMS.

  • Support Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

  • 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.

  • Performs other related duties and responsibilities, on occasion, as assigned

Your experience(s), education and knowledge will further expand Abbott's marketplace success:

  • BS degree in Engineering or Technical Field or equivalent experience

  • 5+ years experience in quality functional roles

  • Demonstrated ability to influence organization and improve processes in a regulated environment.

  • Medical Device manufacturing experience (FDA Class III preferred).

  • Exceptional communication and interpersonal skills

  • Unwavering ethical resilience, high standard of personal integrity, and a non-financially encumbered moral compass.

  • Demonstrated experience with Domestic and International regulatory requirements and regulating bodies required.

  • Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams

  • Experience working in a broader enterprise/cross division business unit model preferred

  • Ability to work in a highly matrixed and geographically diverse business environment

  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results

  • Ability to work effectively within a team in a fast-paced changing environment

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

  • Multi-tasks, prioritizes and meets deadlines in timely manner.

  • Prior medical device experience, or other regulated industry

  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.

  • Ability to travel approximately 10%, including internationally.

  • Ability to maintain regular and predictable attendance.

Your preferred qualifications and education:

  • Advanced Degreee

  • Black Belt certification

  • ASQ certification(s)

  • Audit experience

JOB FAMILY:Engineering

DIVISION:CAHF Cardiac Arrhythmias & Heart Failure

LOCATION:United States > Texas : 6901 Preston Road

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
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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 Abbott Laboratories Plano TX

Senior Quality Systems Engineer

Abbott Laboratories