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Sr. Quality Assurance Engineer

  • Anywhere

Company :
Leica Biosystems

Location :
Bothell, Washington

Expiry Date :
Mon, 26 Apr 2021 23:59:59 GMT

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Description :
At Cepheid, we are passionate about improving health care through faster, more accurate diagnostic tests. As a member of our team, you ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us, every moment of every day, as we develop rapid groundbreaking solutions to solve the world s most complex health challenges. Our associates are involved in every stage of molecular diagnostics from ideation and innovation through development and delivery of life-changing advancements in healthcare-associated infections, sexual health, critical infectious disease, virology and oncology applications. For more details, visit us at or follow us on Twitter. (@CepheidNews) As part of the Danaher family of companies, our work at Cepheid is supported by a global science and technology innovator. In addition to Danaher s unrivaled leadership training and professional development programs, this relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life s Potential. Position Description: The Sr. Quality Assurance Engineer will provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and Operating Company standards. The individual may be responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development and manage process and product non-conformances in line with company procedures. The Sr. Quality Assurance Engineer may also conduct quality assurance tests to ensure product specifications are met and review, investigate, resolve and report on quality discrepancies. The individual will develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards while being able to monitor, investigate, and report on customer complaints. The individual may obtain the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development and lead audit and inspection preparation, resolution of audit and inspection findings. The individual will have frequent interaction with other functional areas and operating entities. Primary Responsibilities: * Lead qualification and validation activities for equipment and facility expansion projects. This includes providing input and approval to design planning, risk management, writing or approving protocols and final reports, providing oversight of protocol execution, deviation investigation and resolution. * Provide support for validation of production processes and test methods. * Represent QA by collaborating on product development teams focusing on design controls, process transfer, validation, monitoring and risk management. * Resolve issues of experimental design and data analysis. * Conduct or support production related investigations driving to root cause determination. * Prepare complex data analysis and write reports, * Review change controls, deviations, CAPAs and other documents and records for accuracy, completeness, and compliance. * Identify compliance gaps, write or revise procedures, and implement processes to improve efficiency while ensuring compliance. * Drive activities supporting Quality System processes to ensure compliance to the Cepheid Quality Management System. * May perform internal audits and training. TRAINING RESPONSIBILITIES: * Complete all assigned and required training satisfactorily and on time Qualifications: * Bachelor s degree in Chemical Engineering or chemistry / life science discipline and at least 5 years of relevant work experience OR Master s degree in field with at least 3 years relevant experience. * Experience with validation writing and coordination of validation program Knowledge and Skills: * In depth knowledge of validation practices. * Works independently, requiring minimal guidance to meet objectives and timelines. * Solves complex problems, works on significant issues, and exercises judgments based on analysis of multiple sources of information to obtain results. * Uses best practices and knowledge to drive improvement. * Experience in the application of production and process controls including validation, process control plans and statistical process control. * Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations. * Effective leadership skills, ability to develop strong partnerships and act as resource to the team. Lead projects with manageable risks. * Highly developed communication skills, ability to influence, build consensus, and work effectively in diverse matrix environment. * Exceptionally strong skills in organization, accuracy, attention to detail and interpreting analytical data. Preferred Qualifications: * Experience in the medical device industry, knowledge of CFR 21 Part 820 (QSR), ISO 13485. * A quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations. Examples include the CQE, CRE, CQA, etc. * Certified in Lean manufacturing and/or Six Sigma. * Knowledge of facility construction Physical requirements/abilities: * Ability to work in an office environment. * Ability to work in laboratory environments. The statements in this description represent typical elements, criteria and general work performed. They are not intended to be a comprehensive list of all responsibilities, duties, and skills for this job. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.