Quality Engineer

Quality EngineerAbbott 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 115,000 colleagues serve people in more than 160 countries.The OpportunityOur location in Temecula, CA, currently has an onsite opportunity for a Quality Engineer. 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.Provide Process/Quality Engineering support on the manufacturing line, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.What You'll Work OnSupport project planning and perform assessments and mitigations with cross functional teams. Develop and manage training programs including training material and training audience. Track and report metrics.Provide support to internal and external audits. Manage relevant audit findings and CAPAs.Continuously improve processes to align with current and emerging regulatory and customer requirements and best industry practices. Collaborate with AV key stakeholders, Abbott corporate functional groups and other Abbott business units.Responsible for compliance with applicable Corporate and Divisional Policies and procedures.Independently, or lead a project team to, identify, plan and conduct medium-size assigned projects requiring a combination of conventional and custom risk-managed execution plans and investigations. manages multiple often concurrent projects.Lead technical projects with inter-coordinating elements where problem resolution may involve the application of new methods and/or approaches and may require consideration of impact with other system components and/or users.Lead and/or participate on cross-functional teams to support organizational goals.Responsible for completing documentation in a timely manner and in accordance with business standards.Serve as a subject matter expert (SME) on a subset or select subsets of a project's technical matters. may interface with external firms or agencies.Responsible for implementing the effectiveness and maintaining compliance of the Quality System. (e.g. compliance with internal procedures and FDA, BSI regulations etc).Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.Assists with evaluating project costs.Identifies, develops and implements processes to improve department performance.Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.Required QualificationsBachelor's degree (Engineering/Life Sciences)2-5+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience.Preferred QualificationsCAPA experienceStrong technical 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.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.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.Demonstrated competency with financial systems and in fiscal controls. Ability to quickly gain knowledge, understanding or skills and is willing to learn.