Senior Supplier Quality Auditor

Abbott Laboratories hiring for Senior Supplier Quality Auditor jobs in Plano, TX, US

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.

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 Plano, TX location in the Abbott Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

The Senior Supplier Quality Auditor will provide technical support in the selection and approval of suppliers and service providers by performing supplier evaluations.

Principle Responsibilities

• Perform quality system and assist in manufacturing process audits at Supplier to applicable standards, regulations and company procedures / policies. 

• Prepare audit report, track report audit results, including corrective actions, and provide follow- up to these actions, as required. 

• Assist in assessing supplier capabilities through direct visits, technical discussions, and quality system audits. Lead supplier development plan as needed. 

• Support supplier qualification activities. 

• Support Supplier Performance Management activities, such as scorecard generation. 

• Support third party and regulatory agency inspections as needed.

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures. 

• Support opportunities for improvements and contribute to solutions. 

• Communicate effectively and efficiently by both written and oral modes.

• Demonstrate excellent interpersonal skills when dealing with internal and external customers.

• Apply problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues 

Required Qualifications

• Bachelor's degree (Engineering preferred) plus 5+ years of related work experience with a strong understanding of regulations and standards (e.g. 21CFR Part 820, ISO 13485, ISO 9001/9100).

• Audit experience

• Analytics experience

• Technical/Business Knowledge

• Solid understanding and application of business concepts, procedures and practices.

• Will perform this job in a quality system environment 

• Proficient in Microsoft Excel, Word, and PowerPoint. 

Preferred Qualifications

• Advanced degree preferred.

• ASQ Certification preferred with 2 years auditing with certification.

• ISO 9001 or ISO 13485 Auditor certified or External Audit related Certification (e.g. Certified Quality Auditor (CQA) 

• Strong understanding of medical device regulations and standards (e.g. 21CFR Part 820, ISO 13485, EU MDD/MDR.   

* 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 $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.