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.

　　Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition.

　　Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health.

　　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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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

　　Personalized healthcare is the future. 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 Quality Engineering Manager position works out of Alameda, CA location.

　　This Quality Engineering Manager position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations.

　　What you’ll do

　　Provide Quality Engineering leadership in direct support of the product lifecycle.

　　Management and development of Quality Engineers.

　　Manage the activities of the Quality Engineering team.

　　Provide Quality Engineering guidance and leadership to department and organization.

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

　　Aggressively identify and manage activities related to adding value to the organization through validation, risk reduction and cost improvement.

　　Provide influential peer leadership with partner sites to drive proactive quality improvements.

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

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

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

　　Oversee or participate in multiple portions of the Quality System, including but not limited to Design Controls, Product Changes, Product Release, NC/CAPA, Supplier Quality, Management Review, and others as needed.

　　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.

　　Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization.

　　Support and or implement all Divisional quality validation initiatives as needed/required.

　　Hire and retain 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.

　　Comply 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.

　　Qualifications

　　Bachelors Degree in related field or an equivalent combination of education and work experience.

　　Minimum 8 years of Quality or Quality Engineering experience in a regulated industry.

　　Minimum 3 years of Supervisory/leadership role.

　　Minimum 2 years of Demonstrated experience in process improvement.

　　Solid working knowledge in FDA 21CFR 820, ISO 9001 ISO 13485, ISO 14971, and/orIEC 62304

　　Demonstrated and impactful strong project management and people leadership skills required.

　　Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.

　　Preferred Qualifications

　　Familiarity with Agile software development and AAMI TIR 4

　　ASQ Certified Quality Engineer

　　Apply Now (https://www.jobs.abbott/us/en)

　　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 (http://www.abbottbenefits.com/pages/candidate.aspx)

　　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 $109,300.00 – $218,500.00. In specific locations, the pay range may vary from the range posted.

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]