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

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
• 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 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

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, CA.  In 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.

• 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.

• Bachelor’s 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.

• Bachelor’s 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.

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