Senior Specialist Quality Assurance

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Senior Specialist Quality Assurance

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locations

United States - Texas - Austin

time type

Full time

posted on

Posted 2 Days Ago

job requisition id

31062475

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.

JOB DESCRIPTION:

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.
This is an on-site daily position
What You’ll Do
As the Senior Specialist Quality Assurance, you will be responsible for conducting and completing quality-related activities to support a third party manufacture (TPM) maintain compliance with Abbott, internal, and external requirements.
MAIN PURPOSE OF ROLE
This position is responsible for providing quality support and oversight on quality compliance related activities supporting a TPM. Specifically,
Provide quality support and oversight (approval) of compliance and audit 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 audit observation responses, 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
Lead quality compliance projects to ensure that equipment, systems, procedures, & processes are compliant and consistent with Abbott and external (e.g. regulatory, standards, etc.) requirements.
Support the TPM in ensuring audit-readiness activities.
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.

Education/Experience
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
$83,000.00 – $166,000.00

In specific locations, the pay range may vary from the range posted.
JOB FAMILY:

Operations Quality

DIVISION:

ADC Diabetes Care

LOCATION:

United States > Texas > Austin : 12501B Research Boulevard

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

No

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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Abbott

is about the power of health. For more than 135 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.

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