Senior Specialist Quality Assurance

in Austin, TX

Senior Specialist Quality Assurance Job

Job Description Job Attributes+

  • Job ID

    31067984

  • Req #

    ABLAUS31067984ENUSEXTERNAL

  • Job Location

    Austin, TX, US

  • Job Category

    Quality

  • Job Type

    Full time

  • Travel

    Not specified

  • Schedule

    40 hours per week

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 Austin, TX location in the Diabetes Care division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

What You’ll Do

As the Senior Specialist Quality Assurance, you will be responsible for conducting and completing quality-related activities for third party manufacturing (TPM) oversight and to support a TPM in maintaining compliance with Abbott, internal, and external requirements.

MAIN PURPOSE OF ROLE
This position is responsible for providing quality oversight of a TPM and supporting quality compliance related activities. Specifically,

  • Manage TPM oversight activities, including but not limited to scorecards, communications, SCARs, etc.,
  • Provide quality support and oversight of compliance readiness activities related to a TPM,
  • Ensure that processes, equipment, and procedures used in the support of the Quality System are maintained in compliance with applicable regulatory, local site, and Abbott requirements,
  • Review documentation (including but not limited to scorecards, communications, change control records, investigations, etc.) for accuracy, clarity, consistency, completeness, and compliance,
  • Plan and complete assignments with a wide degree of difficulty while maintaining milestones established in the project schedule,
  • Analyze data, procedures, and requirements to ensure quality and compliance,
  • Collaborate with alternate functional teams (including but not limited to engineering, operations, regulatory, program management, and other quality teams) to ensure consideration is given to financial and business outcomes when making quality decisions,
  • Coordinate activities across multiple project groups,
  • Accept ownership and responsibility for decisions,
  • Effectively engage with team members within Abbott and TPM teams, and
  • Provide guidance, coaching, and training to various functions and colleagues.

MAIN RESPONSIBILITIES

  • Complete and provide support (including approval) on TPM oversight activities, including but not limited to scorecards, communications, SCARs, etc.
  • Lead quality compliance projects to ensure the TPM is compliant to regional-specific requirements, as applicable, prior to product manufacture & distribution.
  • Manage quality oversight of implementation of ADC-driven changes (BOMs, parts, specifications, drawings, etc.) into the TPM’s quality system.
  • Manage and maintain site quality metrics & dashboards, including the development of metrics and dashboards.
  • Ensure metrics are being met, and develop & drive improvement plans for metrics as needed.
  • Ensure adherence and support maintenance of the effectiveness of the Quality System, including the Subsystems and Key processes by promptly addressing non-compliance issues.
  • Demonstrate good, general understanding of the standards and regulatory bodies that regulate the medical device industry when making decisions and leading projects.
  • Provide solutions to a wide range of difficult problems and implement tactical solutions which meet compliance and business needs.
  • Recognize project interdependencies and with minimal oversight, lead complex quality discussions across various departments including, as needed, external suppliers.
  • Take responsibility & accountability for defining project goals and milestones as well as timely project completion.
  • Communicate confidently and effectively with management, peers, and key stakeholders.
  • Lead quality projects with cross-functional team or broader scope (e.g. multi-site scope), as assigned.
  • Directly influence project direction and scope.
  • Work independently with objectives given by the Quality Manager.
  • May represent own team while on cross-functional project teams with other functional leaders.
  • Identify areas for process improvement and provides supporting information for change, including reasons and justifications.
  • Assist team members and cross functional colleagues in meeting their goals by providing training, coaching, and/or mentoring, as needed.
  • May provide oversight to one or more QA professionals and/or contractors.
  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
  • Support projects and Divisional initiatives as identified by management.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications

Bachelors Degree In Life Science, Engineering, or closely related discipline or an equivalent combination of education and work experience

Minimum 5 years In Quality or related field experience; Less experience may be appropriate with advanced degree.
 

Preferred Qualifications

Quality experience in the medical device or pharmaceutical manufacturing industries.
History of completing successful projects and driving positive compliance outcomes.

Apply Now

* 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 base pay for this position is $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.

Job Skills

  • quality compliance
  • quality assurance
  • quality metrics
  • pharmaceutical manufacturing
  • work independently
  • medical devices

Additional Information

Who We Are

PUT YOUR TALENTS TO WORK

Abbott values the leadership skills developed through military service and we have a broad range of functional areas to put your talents to work. Our organization is making a difference in the lives of the people we serve with a diverse offering of healthcare products. We have a strong veteran employee community to help with your transition from the military to the corporate world.

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