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. **Job Title** **Quality Manager** **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. + 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 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 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. **The Opportunity** Our location in **Sylmar, CA** currently has an opportunity for a **Quality Manager** . **This is a fully onsite role** . The Quality Manager is responsible for implementing and maintaining an effective Quality System. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. **WHAT YOU’LL DO** : + Responsible for implementing and maintaining an effective Quality System as it relates to Post Market and Management Responsibility + Independently lead groups and projects to resolve complex issues. analyze complex problems and identify their impact. establish probabilities. draw conclusions reflecting broad business needs. ensure compliance. + Cross-functionally lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, quality audits, validation. + Works under general direction; independently determines and develops approach to solutions; work is reviewed upon completion for adequacy in meeting objectives. + Makes timely and effective decisions related to business issues within scope of responsibility; appropriately elevates high risk issues / decisions; identifies and quantifies risks and their consequences relative to the success of a project / task; recommends appropriate action; decisions or recommendations would typically achieve departmental / project objectives. + Drives functional performance that ensures cross-functional standards and expectations are met; aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc. + Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility. + 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. + 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 + Travel up to 10% of the time both domestically and internationally by any means necessary to support organizational goals **Required Qualifications** + Bachelor’s Degree in Engineering or Technical Field or an equivalent combination of education and work experience. + Minimum 8 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. + 3-5 years in a supervisory/leadership role. + Relevant experience, such as Quality, Compliance, Engineering, within a regulated environment, such as medical device, diagnostics or pharmaceutical industries, to develop the competence required to meet the skills and responsibilities of the position. + Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with regulatory body. Knowledge of software regulations and compliance (21 CFR Part 11); - Knowledge of ISO 13485. + Knowledge of quality management techniques and the application and principles of quality engineering. Strong knowledge and application of concepts, practices and procedures. Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors. Understanding of statistics. + Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior. Ability to work independently and in groups; ability to work cross-functionally. Demonstrated initiative and problem-solving skills and critical-thinking skills. Ability and aptitude to use various types of databases and other computer software. Ability to prioritize. Strong organizational and project management skills. Ability or aptitude to lead without direct authority. **Preferred Qualifications** + MBA preferred + Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, Strong project management and people leadership skills Please note that the salary range listed is our full grade range. We usually hire based on the mid-point. 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 and @AbbottGlobal. The base pay for this position is $112,000.00 – $224,000.00. 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