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 your 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.

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.

The Opportunity

This position works out of our Alameda, CA location in the Lingo Division. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. 

This Sr. Manager, Tech Quality Assurance is responsible for providing assurance that product hardware and software are developed, validated and maintained in compliance with regulatory and corporate requirements.

What You’ll Work On

Provide Quality leadership in direct support of implementation and maintenance of the Product and software lifecycles.

Lead, oversee or contribute to multiple portions of the Quality System, including but not limited to Design controls, software development, risk management, Product changes, product Release, NC/CAPA, and others as needed.

Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic, and international quality regulations and applicable quality certification requirements

Identify Quality Initiatives and lead cross-functional teams to complete them.

Management and development of Quality Engineers, Specialists, and/or other staff on the Quality Assurance Team.

Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.

Staff and support projects for Lingo products in line with business goals and quality system requirements

Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of product hardware and software.

Provide proactive, diligent, and fact-based communication to Sr. Management, peers, and team.

Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.

Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.

Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

Bachelor’s Degree, preferably in Engineering, Technical Field, Life Science, or closely related discipline.

6+ years’ experience in a Software Quality Assurance experience in a medical device company 

2+ years’ experience leading technical and/or quality professionals.

Knowledge of FDA QSR, ISO13485, ISO14971 and IEC62304

Preferred Qualifications

Prior experience in a medical device company with mobile application software (iOS, Android) highly preferred

Knowledge of Jira, Confluence, ALM Quality Center, and/or other software development and test tools is a plus. 

ASQ Certifications a plus.

Apply Now

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.

The base pay for this position is $128,000.00 – $256,000.00. In specific locations, the pay range may vary from the range posted.