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Manager, Quality Engineering

Company: Abbott Laboratories
Location: Des Plaines
Posted on: January 12, 2021

Job Description:

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 107,000 colleagues serve people in more than 160 countriesAt Abbott Molecular, we realize the potential of personalized care as the laboratory's most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics.WHAT YOU'LL DO 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.* Provide Quality Engineering leadership in direct support of medical device manufacturing.* Management and development of Quality Engineers and Technicians.* Manage the activities of the Post-Production Quality Engineering team.* Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.* 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.* Define and implement superior Process Control & Monitoring systems for KPIV and KPOV throughout the product lines - Critical Parameter Management.* 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 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.* Oversee 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.EDUCATION AND EXPERIENCE YOU'LL BRING * Bachelor's Degree (-- 16 years) in Engineering or technical discipline, or equivalent experience* Minimum of 8 years Class III or II medical device or pharmaceutical experience. Roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired.* Minimum of 3 years in a Supervisory/leadership role.* Six Sigma Green or Black Belt preferred. ASQ Certified Quality Engineer strongly preferred.* Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.* Ability to travel internationally to support international manufacturing sites. 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.* Demonstrated competence 5+ years applicable engineering experience in equipment, molding, packaging, industrial design, project management or related field and 5+ years experience in design control, qualification, FMEA, specification and drawing control.* Experience working in a broader enterprise/cross division business unit model preferred. 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 approximately 10%, including internationally.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 Learn more about our benefits that add real value to your life to help you live fully:? www.abbottbenefits.com 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. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott--and on Twitter @AbbottNews and @AbbottGlobal.

Keywords: Abbott Laboratories, Des Plaines , Manager, Quality Engineering, Executive , Des Plaines, Illinois

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