JOB DESCRIPTION:The OpportunityThis position works out of our Austin, TX location in the Abbott Diabetes Care division where we are 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 role manages the Quality System for third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance. The role is responsible for keeping all the QS elements consistent and effective for its purpose. Ensures implementation of TPM related Quality Assurance policies and procedures generated conform to predetermined Corporate/Division standards and specifications.
What You'll Work OnManage the Quality System for US third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance.
Systems include:
• Nonconformance and CAPA
• Change control
• Complaints
• Batch release
• Label development and control
• Related budget elements
• Management reviews
• Audits
Provide quality support for questions related to products compliance queries, complaint investigation, nonconformance and compliance audit preparation.
Ensure implementation of TPM related Quality Assurance policies and procedures generated conform to predetermined Corporate/Division standards and specifications.
Ensure quality system infrastructure and standards are in place and maintained at US TPMs to meet compliance and timeliness requirements. This is done through the quality systems monthly reviews and MOS tier process, ongoing business maintenance, and tracking and trending.
Effectively identifies and develops staffing requirements: • Develop practices that ensure a diverse work force and improved job performance.
Manage a staff to support batch release, inventory turns, product holds and multi system product traces.
Required Qualifications
- Bachelor's degree and minimum 7 Years of experience, both overall and any industry specific experience needed.
- Strong business acumen and cross functional experience (quality, engineering, opex).
- Experience in dealing with regulatory authorities such as FDA.
- Managerial/leadership experience.
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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.
The base pay for this position is $129,300.00 - $258,700.00
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:No
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
