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 114,000 colleagues serve people in more than 160 countries. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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. + Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. + An excellent retirement savings plan with a high employer contribution + Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree. + A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This position works out of our Portland, OR location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Manager Quality Engineering 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 Work On** + 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 1s 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. **Required Qualifications** + Requires a B.S. in Engineering degree (e.g., Mechanical, Biomedical, Materials, or Manufacturing Engineering).  + Requires 8 years of experience on Class III or II medical device experience. Roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality. + Requires 3 years of experience in supervisory/leadership role. + Engineering experience, including skills in new product introduction, process development, improvement, and validation related.   + Requires strong analytical, written, and verbal communication skills and the ability to interface with all departments.   **Preferred Qualifications** + Experience with FDA design controls for medical devices (ISO/GMP) preferred.  + Industry experience with medium to high-volume manufacturing is strongly preferred.  + 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. Apply Now (https://www.jobs.abbott/us/en) **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx) 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 $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com