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Quality Engineer III (Design Quality Engineer

Company: ALERE
Location: San Diego
Posted on: January 17, 2020

Job Description:

Quality Engineer III (Design Quality Engineer) ["NA-USA-California-San Diego"] Position Title: Senior Quality Engineer Location: San Diego, CA DO WORK THAT MATTERS At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals. We have an exciting opportunity for a Senior Quality Engineer within our Abbott Rapid Diagnostics business located at San Diego, CA. In this role, you will be responsible for design quality engineering activities that span the product development process and design transfer to manufacturing. You will develop risk management documentation to address product design and process changes, product and process quality issues and compliance issues. You will have an opportunity to partner with Research & Development to facilitate the design control process and act as Quality Lead for all new product initiatives. This person may lead or support in the supplier management related activities for development of new products including but not limited to: supplier selection and qualification, component qualification, contract development. Abbott Rapid Diagnostics (formerly Alere) is part of Abbott s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. RESPONSIBILITIES * Lead the design and development/on market support of IVD medical device products, facilitating the application of design/change controls, risk management, quality plan and implementation of design and development plan. * Create and maintain risk management files such as UMFMEA/DFMEA/PFMEA that identify Hazard Analysis Critical Control Points (HACCP) and are compliant with the requirements of ISO 14971:2012. * Lead design verification, design validation, and design history file (DHF) creation and maintenance. * Facilitate risk management reviews and FMEA sessions. * Author validation master plans. * Review and approve verification, design and process validation documentation and equipment qualification documents. * Act as SME for key subsystems such as design control, risk management, Design Verification, Design Validation, Process Validation etc. * Work closely with R&D, Manufacturing, Quality Control, and Applications Support management to prevent non-conformities and provide solutions to complex issues. * Lead and support multiple projects, balancing priorities and resources to meet project and management expectations. * Lead process improvement projects * Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. * Demonstrates good judgment in selecting methods, regulatory standards and techniques for obtaining solutions. * Facilitate design transfer of products from development to production. * Review and approve proposed changes for on market products by performing risk assessments, providing guidance and support and assessing the adequacy of verifications and validations and DMR documents. * Perform root cause analysis of product quality issues. Apply appropriate tools (e.g. statistics, fault tree analysis, etc.). Work with peers to develop corrective actions. * Perform failure mode analysis on new or existing products. Ensure all reasonable failure modes are identified. Working with peers, develop mitigations for failure modes, and verify the effectiveness of these mitigations. * Coordinates for both new products/processes and changes to existing products/processes develop verification and validation plans that assess if requirements are met. Oversee the execution of verification and validation plans in conjunction with validation and process improvement engineers. * Resolve QI and CAPA by performing investigations, conducting root cause analysis, developing and implementing plans to resolve. BASIC QUALIFICATIONS * BS/BA degree in Chemistry, Microbiology, Biology, Biochemistry Engineering or equivalent in related field or equivalent experience * Minimum of 7 years experience in a quality role within the Biotechnology industry with 3-5 years of progressively responsible positions * Minimum of 5 years hands-on risk management experience in developing and maintaining risk management files such as UMFMEA/DFMEA/PFMEA, plans and reports * Minimum of 5 years of quality engineering experience (design controls/change control, process validation, on market engineering support and risk management) in a regulated environment. * Experience reviewing and approving plans and reports for design verification, design validation, and process validations. PREFERRED QUALIFICATIONS * Direct work experience in IVD or medical device/biotech or regulated manufacturing environment. * Experience with lateral flow devices / biological reagent-based devices. * Experience with software, firmware and reader-based devices. * Knowledge of IEC 60601 and IEC 62304 standards. * Experience coordinating QA activities of a medical device/IVD contract manufacturer. * Process, QMS, or Supplier auditing experience desired. * Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor desired. * Knowledge of IVDR in EU, FDA QSRs, ISO 13485:2016, ISO 14971:2012 standards and HACCP, GMP, GLP and GDP requirements. * Goal oriented, learns quickly, works in a collaborative manner with other departments. * Experience with MS Word, Excel, Access, Visio, MS Project, Minitab, PowerPoint and Agile. * Statistical tools including basic statistical inference, graphical methods, regression. * Able to work on multiple tasks as a team and operate as an individual contributor. * Available for flexible work schedule. COMPETENCIES * Analytical Skills (e.g. statistical, risk analysis, engineering analysis) * Team player * Interpersonal Skills * Drives for results * High level of attention to detail * Collaboration About AbbottAt Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to *********************. Full-time

Keywords: ALERE, San Diego , Quality Engineer III (Design Quality Engineer, Engineering , San Diego, California

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