Description:The Senior Quality Assurance Scientist initiates, designs, develops and implements product design improvements and changes where analysis of situations or data requires a review of identifiable factors. In this role, the Senior QA Scientist O rganize and monitor field evaluations of current and new products for customer acceptance and validation Develop, recommend and review system design evaluations, service/maintenance plans and procedures, operator manuals and reliability requirements Directly assist customers on product performance issues T eam with Engineering and other departments to troubleshoot instrument and chemistry problems A ssist with product definition and specification development D evelop and execute test protocols to assess feasibility of product modifications P repare service documents R epresent QA on current business or product improvement projects Assure accuracy of product labeling and compliance Generate, prepare and issue complex data for assigned quality reports. Provide Quality Assurance support for Reagent manufacturing of medical devices. Ensure compliance to design change procedures, corporate policies, and global regulations (FDA QSR, ISO, etc.) and make decisions/provide guidance to prevent a deviation or non-conformance Work with cross-functional team to identify, contain and disposition non-conforming product Effective interaction with development, technical operations, and manufacturing staff to ensure quality, strive to minimize the costs of reworking or waste and maximize customer satisfaction with the products Establish and drive to daily management actions for quality processes that support corporate initiatives Evaluate quality system performance and lead kaizen events to improve process efficiencyAdditional Skills & Qualifications:Qualifications: BS, BA in a Life Science or related studies 5+years in IVD industry or experienced with medical devices. Experience working in Quality Assurance Experience with medical device industryExperience Level:Intermediate LevelAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
