Senior Specialist Quality Assurance Job
Job Description Job Attributes+
Austin, TX, US
Yes, 10 % of the Time
40 hours per week
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.
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.
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.
As the Senior Specialist Quality Assurance you will be responsible for conducting quality-related activities to deliver consistent; high quality documents; services; products and processes.
What You’ll Work On
Provides solutions to a wide range of difficult problems.
Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
May Leads quality projects with cross-functional or broader scope.
Defines project goals and milestones.
Responsible for timely project completion.
Interacts effectively with employees, manager, and cross-functional peers.
May represent own team while on cross-functional project teams with other functional leaders.
Communicates confidently and effectively with management, peers, and key stakeholders.
Implements tactical solutions related to assignment.
Able to contribute functional skills and expertise broadly.
Directly influences project direction and scope. Scope includes one or more QA functions, with general knowledge of other
Provides guidance and trains others. May provide oversight to one or more QA professionals
• Quality System Compliance:
Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry.
Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.
Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
• Risk Management:
Ensures evaluation of product safety and efficacy and elevation of risk-based issues.
Creates and reviews risk management documentation to reduce or eliminate risk.
Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system. Authors risk control packages and demonstrates the ability to analyze, evaluate, and control risk decisions by utilizing common practices throughout the quality.
•Design Control / Documentation & Change Control:
Formulates thorough reason and justification for change.
Identifies critical parameters associated with change.
May represent the site as an SME or Process Community member.
• Quality Engineering:
Applies solid understanding of quality system elements from product inception through launch.
While recognizing project interdependencies and with minimal oversight, leads complex quality discussions across various
departments including, as needed, external suppliers.
May act as Subject Matter Expert (SME) for minimum of at least one respective Validation Subsystem.
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 experience in the Healthcare industry.
Has a history of completing successful projects and driving positive compliance outcomes.
* 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.
The base pay for this position is $80,700.00 – $161,300.00. In specific locations, the pay range may vary from the range posted.
- Risk Control
- CHANGE CONTROL
- Risk Management
- Project Direction
- Tactical Solutions
- Quality Assurance
- risk management documentation
- Quality System Compliance
- Product Safety
- Design Control
- CHANGE CONTROL
- Design Control
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.