Senior Manager Supplier Quality

Thornton Tomasetti; Texas; On-site; USD 129,000 - 259,000; Full time

Benefits offered by this job

Free medical coverage

Excellent retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott in Austin, TX is seeking a qualified Quality System Manager to oversee the Quality System for US third‑party manufacturing in line with Corporate and Divisional standards, ensuring TPM performance and compliance.

You will lead CAPA, change control, complaints, batch release, labeling and related budgets, with strong regulatory experience including FDA interactions, and mentor a staff to support product quality across the TPM network.

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.

Responsibilities

• Manage the Quality System for US third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance.
• 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.

Skills

Quality Assurance

Leadership

Cross-functional collaboration

Regulatory experience

Education

Bachelor's degree

Job description

Company Overview

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.

JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

Opportunity

The Opportunity This 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.

Roles & Responsibilities

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 On

• Manage the Quality System for US third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance.
• 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.

Salary

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 Details

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)

Equal Opportunity Employer

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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

Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

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 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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