Quality Engineer II

Quality Engineer II Location: Salt Lake City, UT, United States Position Type: Unfixed Term Job Function: Quality Share: share to e-mail Share on Facebookshare to facebook Tweetshare to twitter Share on LinkedInshare to linkedin Apply Now > A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada. Come and join a family-owned global company with a long-term vision, and a human-centered culture. Description Position Summary: Ensures, through global and local Product Development Process procedures and efforts, that Molecular products are developed, tested and transferred to manufacturing according to established procedures that will assure that they meet all quality requirements. Responsible for the implementation and maintenance of effective Quality Systems in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485 and other applicable country specific regulations. Participates and provides guidance to quality improvement teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement. Primary Duties: Perform all work in compliance with company quality procedures and standards. Quality Engineering Support for the Molecular RandD Design Control Process - Design, approve, and implement development effort/project planning as needed, review and approve project documentation as requested. Represent the Quality RandD function by participating in design reviews, developing quality engineering deliverables and assuring Design History File (DHF) is updated and reviewed for accuracy/ completeness when necessary. Provide guidance / support to program directors, project managers, product development teams, RandD, and Product Validation functions regarding application of design controls, scalability, and related development process practices and improvements. Contribute to the documentation of quality systems and programs in the area of training, change management, design control, including product verification and validation, CAPA for relevant design issues, documentation control considerations, etc. to ensure compliance with FDA and regulatory requirements. Develop and execute design control training programs (e.g. design change control, risk analysis, etc. as requested). Prepare for and support regulatory and agency inspections/audits (FDA/ISO/MDSAP/etc.), investigations, and inquiries regarding the control and assessment of product design quality. Support corporate/internal design control audits. Participate in site RandD CAPA activities and non-conformities/deviations including investigation, effectiveness, and root cause analysis, etc. Coordinate implementation of corrective actions and preventive measures, as needed. Function as QA subject matter expert for cross-functional development team related practices: facilitate risk management activities, provide guidance for strategy and content of requirements and specifications. Provide strategies and approvals for verification methodologies, configuration management, validation, and regression testing approaches. Ensure the maintenance of the Risk Management File of the products in your portfolio Training and Education: Required- Bachelor's Degree in science or engineering discipline. Master's degree in a scientific discipline is preferred, minimum (5) years of relevant Health Industry (IVD, MD, Biotech or Pharm a) experience within RandD, Product Development, Design... For full info follow application link.