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Manager Quality Assurance

Company: Abbott Laboratories
Location: Plymouth
Posted on: April 3, 2021

Job Description:

Quality United States - Minnesota - Plymouth 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 109,000 colleagues serve people in more than 160 countries. (Structural Heart)--Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care. This position 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. WHAT YOU'LL DO-- --- Management and development of Quality Systems Engineers. --- Administer and lead Corrective/Preventive Action program for all MCS sites (five different locations). --- Oversees the CAPA process from initiation to effectiveness review and ensure 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 international partner site 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. --- Maintain effective Quality Metrics and 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. Identify Quality Initiatives and lead cross-functional teams to complete them. --- Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner. --- Produce and analyses trend metrics and reports and establishes further actions, as may be required. --- 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. EDUCATION AND EXPERIENCE YOU'LL BRING-- Required--

  • Bachelor's degree in related field
  • 8-10 years roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired. Industry certification preferred.
  • Class III or II medical device experience.
  • Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.
  • Experience with validating processes or products. Engagement in master validation plans/reports is preferred. Preferred--
    • 3-5 years in a supervisory/leadership role.
    • Six Sigma Black Belt strongly preferred. 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-- Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.-- Get tailored job recommendations based on your interests.
        • JOB ID: 30971825
          • LOCATION United States - Minnesota - Plymouth
            • DIVISION SH Structural Heart
              • TRAVEL Yes, 10 % of the Time
                • MEDICAL SURVEILLANCE No
                  • SIGNIFICANT WORK ACTIVITIES Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday) Our business encompasses many different functions and capabilities, which allows you to explore careers in various fields.-- GROWTH PLANNING Growth Planning and Performance Excellence is an annual process through which you'll be able to have open career discussions with your manager to help you determine your own career path and future. TRAINING & NETWORKS We provide a wide range of classroom and e-learning courses to help you develop new skills and enhance your career.-- WE'RE RECOGNIZED AROUND THE WORLD DOW JONES SUSTAINABILITY INDEX BEST CORPORATE CITIZENS FORTUNE CHANGE ---------------------THE WORLD FORTUNE'S MOST ADMIRED COMPANIES JOIN OUR TALENT COMMUNITY We will notify you about relevant positions, and keep you in mind whenever we have interesting opportunities.-- Abbott welcomes and encourages diversity in our workforce including Minorities, Women, Individuals with Disabilities and Protected Veterans. We provide reasonable accommodation to qualified individuals with disabilities. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

Keywords: Abbott Laboratories, Plymouth , Manager Quality Assurance, Executive , Plymouth, Massachusetts

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