Senior Quality Engineer - New Product Development

Abbott in Temecula, CA

  • Industry: Engineering - Others
  • Type: Full Time
position filled
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 103,000 colleagues serve people in more than 160 countries. Job Description: Provide Process/Quality Engineering support to manufacturing, 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. Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members. Core job responsibilities include: Creating and maintaining Risk Analysis documentation. Executing benchtop Filing and Aging studies, including ownership of protocols, reports, and statistical analysis of data. Creating Inspection and Control Plans. Supporting Test Method Development and Test Method Validation, Process Validation, and Supplier Validation activities. Supporting conformance to external standards and global Regulatory Submissions. Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.. Collects and analyzes Manufacturing process defect data. Leads Product/Process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development. Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams May be responsible for implementing product stops & documenting release criteria Accountability / Scope (Influence/Leadership) + Establishes and cultivates an extensive network of support to facilitate completion of assignments. + Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. + May lead a project team. + Participates in determining goals and objectives for projects. + Influences middle management on technical or business solutions. May interact with vendors. (Planning/Organization) + Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments. (Decision Making/Impact) + Exercises judgment in selecting innovative, practical methods to achieve problem resolution. + Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources. Education / Experience Bachelor's degree (Engineering - prefer EE) plus 5-7+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred. ** Medical Devices experience is REQUIRED. ** R&D Support experience ** Experience with Risk Management ** Experience with New Product Development ** Experience with Regulatory Submissions ** Experience with protocols/support reports (Technical/Business Knowledge (Job Skills) Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies/ relationships. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.; (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. NO RELOCATION ASSISTANCE IS AVAILABLE WITH THIS POSITION. 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 </script>

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