Quality Professional

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

Conducts internal quality audits to assess compliance to the requirements of FDA, ISO, MDD, CDR, Japan, and other regulatory bodies applicable to the Quality System. To participate in and support the division during external regulatory audits.

What You'll Work On

This position works out of our Alameda, CA location in the 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.

• Lead/support assigned divisional internal/clinical/supplier audits to maintain timely closure of the audit cycles
• Support Audit Readiness activities for external audits including training staff /guidance in preparation of external audits
• Support compliance gap management activities e.g. compliance risk management- Identifies risks to the business and resolutions to address compliance gaps.
• Assist management of near miss program
• Support tracking of  regulations and industry standards revisions. Evaluate and communicate the impact of these revisions with the related departments and follow up compliance to these revisions.
• Prepares/ reviews/analyses metrics data
• Promotes awareness and understanding of quality & compliance within the division. Provide training to the division to increase compliance awareness
• Participate in compliance initiatives and other assigned projects

Required Qualifications

• AS or BS degree or combination of appropriate education and experience.
• With a 2- or 4-year degree, 5 years of experience in the medical device industry and 5 years auditing per ISO and/or FDA standards.
• Excellent writing skills are required. Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
•  Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel, including internationally.

Preferred Qualifications

• Lead Auditor Certification for ISO 13485 or 9001:2000 preferred.

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/Abbottand on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $73,600.00 – $147,200.00. In specific locations, the pay range may vary from the range posted.

• fda
• regulatory audits
• quality systems
• external audits
• supplier audits
• medical device industry
• medical devices
• quality compliance promotion
• compliance risk management
• risk management
• mdd
• business unit model
• revision management
• iso 13485