Sr. Manager, Tech Quality Assurance – Lingo (on-site)

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 115000 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. Youll also have access to:

• Career development with an international company where you can grow the career you dream of
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
• 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 bachelors 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.

We are recruiting for a Sr. Manager Tech Quality Assurance to join our team on-site in Alameda this role you will be responsible for providing assurance that product hardware and software are developed validated and maintained in compliance with regulatory and corporate requirements.

What Youll 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

• Bachelors Degree or an equivalent combination of education and experience
• Minimum 7 - 9 years related work experience.
• Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals.
• Monitors costs of projects and of human and material resources within a department or unit.
• Monitors external environment in area of technical or professional responsibility.
• Will perform this job in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups
• Investigates and solves problems that impact work processes and staff within or across units or departments.
• Communicates the departmental vision for the organizational unit assigned.

PreferredQualifications

• Bachelors Degree preferably in Engineering Technical Field Life Science or closely related discipline.
• 6 years experience in a Software Quality Assurance role in a medical device company.
• 2 years experience leading technical and/or quality professionals.
• Knowledge of FDA QSR ISO13485 ISO14971 and IEC62304
• 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.
• Advanced degree
• Effective verbal and written communication with diverse audience and team.
• Analytical thinking with good problem-solving skills.
• Must be able to lead and manage multiple and competing priorities and manage programs.
• ASQ Certifications a plus.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

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 on Facebook at and on Twitter @AbbottNews.Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

$130700.00 $261300.00

In specific locations the pay range may vary from the range posted.

Operations Quality

LNGO Lingo

United States > Alameda : 2901 Harbor Bay Parkway

Standard

Yes 10 % of the Time

No

Awkward/forceful/repetitive (arms above shoulder bent wrists) Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: EEO is the Law link - Espanol: Experience:

Manager