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. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. **Our location in Temecula, CA, currently has an opportunity for a Quality Engineer.** **THIS POSITION IS AN ON-SITE DAILY REQUIRED ROLE.** **What you'll do:** Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer and provide support to product development teams, helping to ensure development of highest quality new products. The Quality Engineer is expected to assist in the identification and resolution of quality related issues. You'll have the opportunity to apply subject matter expertise, in an individual contributor role with limited supervision. Expected to provide quality engineering support to the site to ensure manufacturing/quality requirements are met and understand and elevate issues related to quality validations. Work with a team to establish and implement a dynamic structure that fosters and ensures consistent compliance to external laws, regulations, guidances and standards that affect the quality system. The team will develop and follow a process to implement a structure that will facilitate a consistent implementation of external quality system standards including leading activities for site inspection readiness. This structure will improve coordination between functions and increase the awareness and compliance of external requirements. **Core Job Responsibilities** + Responsible for compliance with applicable Corporate and Divisional Policies and procedures. + Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements + Assist in the review and/or development and execution of streamlined business systems which effectively identify and resolve quality issues + Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues + Lead the investigation, resolution and prevention of product and process non-conformances + Manages monthly Quality Data Review and/or quarterly Management Review activities for the Site and ensures accurate information is provided at the site level + Ensures compliance with FDA and global regulatory agency requirements for manufacturing site registrations and device listings + Lead and Support all site announced and unannounced site inspections/audits from both internal and external agencies, including site preparation/inspection readiness. + Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. + May be responsible for querying & boundingdata to support implementation ofcomplex & documenting release criteria. + Develops product quality plans, documents and systems bycreating product specifications, quality specifications and quality plans in conjunction with other productdevelopment team members. + Leads process improvement efforts by identifying methods tocapture quality metric data and by performing appropriate analysis methods to enhance sustaining productdesign and new product development. + Assists in creation of Quality Tools & Training Materials byunderstanding the limitations of existing quality tools and training materials, and by helping to identify moreeffective tools & materials. + 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 + Supervisory / Management Responsibilities (Supervision Received) Works under general supervision. Follows established procedures. Work is reviewedfor soundness of technical judgment, overall adequacy and accuracy.; (Supervision Provided) May providelimited work direction and guidance to exempt and/or skilled nonexempt levels of employees; may be asked toevaluate performance of and assist in career development planning for subordinates.Position Accountability / Scope (Influence/Leadership) Cultivates a wide range of internal networks and begins to develop an extensiveexternal network of resources to facilitate completion of tasks. May lead a project team of moderate scope. Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors. Influenceexerted at peer level and occasionally at first levels of management.; (Planning/Organization) Plans,organizes, and prioritizes own daily work routine to meet established schedule.;(Decision Making/Impact)Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieveresults or erroneous decisions or recommendations may cause delays in program schedules and may result inthe allocation of additional resources. **EDUCATION AND EXPERIENCE YOU’LL BRING** **Minimum Education** • Bachelor's degree plus 2 - 5+ years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2 years of related work experience, or an equivalent combination of education and work experience **Minimum Experience / Training Required** Will perform this job in a quality system environment. Failure to adequately perform tasks can result in a noncompliance with governmental regulations.; * CQE Certification a plus * Medical Devices experience preferred * CAPA experience * Experience working with Quality Systems * Data Analysis experience * Risk Management experience (Cognitive Skills) Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact. (Technical/Business Knowledge (Job Skills)) Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.; **WHAT WE OFFER** At Abbott, you can have a good job that can grow into a great career. We offer: • A fast-paced work environment where your safety is our priority • Production areas that are clean, well-lit and temperature-controlled • 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 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 $60,000.00 – $120,000.00. 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