JOB DESCRIPTION:
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
- 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](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.
We are recruiting for a Senior Manager, Quality Systems to join our team on-site in Alameda, CA. In this role, you will ensure effectiveness of the quality system and consistent compliance to external laws, regulations, guidances and standards (LRGS). Implement and manage a structure that will facilitate a consistent implementation of quality systems. Maintain coordination between functions and increase the awareness and compliance within the quality systems processes.
What You’ll Work On
- Recruit, coach and develop organizational talent.
- Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Create an entrepreneurial environment.
- Provide direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.
- May manage and coach a team of quality assurance employees.
- Keep the organization's vision and values at the forefront of decision making and action.
- Demonstrate effective change leadership.
- Build strategic partnerships to further departmental and organizational objectives.
- Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
- Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
- Make decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
- Develops, monitors and appropriately adjusts the annual budget for department(s).
- Coordinate the implementation of quality system requirements at Abbott Lingo.
- Assess proposed regulations and communicate new requirements to the organization.
Required****Qualifications
- 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.
Preferred**Qualifications**
- Advanced degree
- Submission / registration types and requirements
- Effective verbal and written communication with diverse audience and team.
- Analytical thinking with good problem-solving skills.
- Experience managing and leading a team.
- Certification is a plus (such as ASQ).
- Must be able to lead and manage multiple and competing priorities and manage programs.
- Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
- Experience with medical device software requirements and software regulations.
- Ability to identify risk areas and escalate issues as appropriate.
The base pay for this position is
$130,700.00 – $261,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
LNGO Lingo
LOCATION:
United States > Alameda : 2601 Harbor Bay Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
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: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
