Quality Assurance Manager (31030798)
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 113,000 colleagues serve people in more than 160 countries.
Quality Assurance Manager
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
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.
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with high employer contribution
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.
This Quality Assurance Manager works in our Gurnee, Illinois location in the RAPID Diagnostics Division. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.
What You’ll Work On 4- 6 Supervisors report to this Manager.
Provide Quality leadership in direct support of medical device manufacturing including incoming material inspections, Quality control testing and final release of production batches.
Management and development of Quality Specialist and Technicians.
Manage the activities of the Quality teams.
Ensures Quality departments support OpEx initiatives including daily Tier meetings.
Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc
Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
Provide influential peer leadership 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
Participates in the Nonconformance and Real-time data management portions of the Quality System
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 all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
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.
Manages GMP records for cataloging, archival, retrieval and scheduled destruction of records in accordance with established procedures.
Demonstrates commitment to the development, implementation and effectiveness of ARDx Quality Management System per ISO, FDA, and other regulatory agencies.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships
Carries out duties in compliance with established business policies
Other duties as assigned, according to the changing needs of the business
Bachelors degree or equivalent combination of education and work experience.
Class III or II medical device experience.
3-5 years in a supervisory/leadership role.
Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.
Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC).
Demonstrated and impactful strong project management and people leadership skills required.
Ability to work in a highly matrixed and geographically diverse business environment.
Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
Ability to work effectively within a team in a fast-paced changing environment.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multi-tasks, prioritizes and meets deadlines in timely manner.
Strong organizational, planning, and follow-up skills and ability to hold others accountable.
Ability to travel, minimally
8 + years in roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality. Industry certification.
Six Sigma Black Belt.
ASQ Certified Quality Engineer.
Experience working in a broader enterprise/cross division business unit model
* 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: [Register to View]
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.