At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
We are presently hiring for a Senior Manager of Quality Assurance CAPA [Corrective Action / Preventive Action] to be based at Division HQs in Alameda CA.
WHAT YOU’LL DO
This highly visible role provides leadership and direction over the Global CAPA Programs and associated QA activities across Abbott Diabetes Care's Product Portfolio.
You'll be responsible for developing, establishing and maintaining CAPA / QA programs, strategies, policies, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations.
As Sr. Manager, you will have the opportunity to lead, grow and develop the team of CAPA QA Specialists / Engineers. Communication and interpersonal skills will be leveraged as you effectively represent CAPA / QA objectives in cross-functional teams. You will initiate and manage continuous improvement efforts, and demonstrate an aptitude for identifying and solving problems.
Lead and manage Corrective/Preventive Action programs for all ADC product operations.
Oversee the CAPA process from initiation to effectiveness review, ensuring the CAPA process is compliant and effective and driving investigations to root cause.
Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
Provide influential peer leadership with suppliers and TPM sites to drive proactive quality improvements.
Identify Quality Initiatives and lead cross-functional teams to complete them.
Provide expert level guidance and direction of the CAPA systems Body-of-Knowledge.
Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
Provides subject matter expertise, leadership and training on investigational & Root Cause Analysis techniques, as appropriate, to other CAPA team members and to technical subject matter experts involved in the resolution of quality issues.
Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.
Manager effective Quality Metrics and trends, define and execute activities to resolve decreases in performance.
Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organ.
Represent Quality Systems as required in support of cross-functional divisional projects.
Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
Approves CAPA investigations and resolution plans, verifies completion of CAPA actions.
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 / suppliers.
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelors Degree or an equivalent combination of education and work experience
Requires 7-10 years of experience in function or related field.
Requires 4-6 years of direct supervisor - staff management - experience.
Must have demonstrated solid knowledge and experience in the discipline. Leadership experience is required. Considered a Subject Matter Expert and key contributor to initiatives.
Must have the ability to problem solve, manage projects, influence internal and external groups, and provide leadership from an Operations and Quality perspective.
Proven ability to successfully lead people and projects and to motivate and influence others are required.
Preferred Knowledge and Skills:
Leader and key contributor to QA initiatives and advancement of a Quality organization.
Builds and drives relationships and teamwork within Department and cross-functions with professional demeanor.
Ability to thrive in fast-paced environment with strict deadlines, works with a sense of urgency and ownership.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
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