AddressAbbott 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.
Manager, Quality Systems - LINGO
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.
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 Manager, Quality Systems 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.
THIS POSITION WORKS ONSITE OUT OF OUR ALAMEDA, CALIFORNIA LOCATION FOR LINGO.
What You’ll Work On
- Provide Quality leadership in direct support of implementation and maintenance of the quality management system.
- Management and development of Quality Engineers, Specialists, and/or other staff.
- Manage the activities of the Quality Systems team.
- Provide Quality Systems 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 the planning, implementation, and optimization of the quality management system.
- 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.
- Lead, oversee or participate in multiple portions of the Quality System, including but not limited to Management Review, Internal Audit, Audit Readiness, NC/CAPA, Document Control, Training, Product Release, 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.
- Support and or implement all Divisional quality validation initiatives as needed/required.
- 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.
- Travel: 10% (domestic).
Required Qualifications
- Bachelor’s Degree, preferably in Engineering, Technical Field, Life Science, or closely related discipline.
- 8+ years’ experience in a Quality or Regulatory experience in a regulated industry.
- 3+ years’ experience leading a team of technical/quality professionals.
Preferred Qualifications
- Prior experience in a software-focused company or company with software as a medical device (SAMD).
- Prior experience in EQMS launches and/or QMS Transitions.
* 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
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 $109,300.00 – $218,500.00. In specific locations, the pay range may vary from the range posted.
