Senior Quality Engineer

Responsibilities Interface with the Operations, Research and Development, and Regulatory functions to coordinate compliance and develop best practices. Develop and implement new and updated Quality System procedures such as SOPS and Work Instructions to support the Quality System. Prepare or input into validation protocols, manufacturing procedures, product & material specifications, design & development documentation, development, risk management and task force projects. Conduct statistical analysis (F-test, t-test, ANOVA, normality tests, etc.) and generate trend reports for projects on an as-needed basis. Utilize Quality Engineering tools and techniques to establish sampling plans, develop quality plans, and conduct process and systems audits. Coordinate the reporting, analysis, and resolution of material non-conformance incidences in conjunction with Operations and R&D. Perform manufacturing and incoming inspection Quality checks. Coordinate the identification, assignment, monitoring, and completion of product improvement projects in cross-functional teams. Assist with Supplier Management as well as plan and conduct supplier quality audits. Plan for internal audit activities to assess compliance with quality system requirements. Assist with resolving internal and external audit findings and observations, non-conformance reports, and corrective actions. Evaluate proposed changes at suppliers and to in-house specifications in conjunction with Operations and R&D. Implement and maintain a risk management process for product and processes in accordance with applicable standards. Oversee and coordinate CAPA activities, including identification, investigation, implementation, and effectiveness of corrective and preventive actions. JOB REQUIREMENTS: Education and Training BS in Engineering (preferred), life sciences or other related field or equivalent experience. Minimum of 5 years of QE/QA work experience in the medical device industry. Technical Requirements Experience with FDA requirements, 21 CFR 820, ISO 13485 and ISO 14971. In-depth experience with risk management, design control, manufacturing sterile products, sterilization validation and CAPA investigations. Strong verbal and written communication skills; must interface well with all levels of the organization. Ability to read and interpret drawings and specifications. Ability to write validation protocols and final reports and oversee validations. Must have initiative, judgment, and ability to manage multiple tasks with frequent interruptions with high attention to detail and accuracy. Excellent ability to work in a team environment and display a positive, can-do attitude. ASQ CQE (Certified Quality Engineer), and/or Certified Auditor certification is preferred.

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