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 organizes and monitors field evaluations of current and new products for customer acceptance and validation; develops, recommends and reviews system design evaluations, service/maintenance plans and procedures, operator manuals and reliability requirements; directly assists customers on product performance issues; teams with Engineering and other departments to troubleshoot instrument and chemistry problems; assists with product definition and specification development; develops and executes test protocols to assess feasibility of product modifications; and prepares service documents. The Senior Quality Assurance Scientist represents 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.

Additional Skills & Qualifications:

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-conformanceWork with cross-functional team to identify, contain and disposition non-conforming productEffective 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 productsEstablish and drive to daily management actions for quality processes that support corporate initiativesEvaluate quality system performance and lead kaizen events to improve process efficiencyBS, BA in a Life Science or related studies5+years in IVD industry or experienced with medical devices.Experience working in a regulated industry It would be a plus if you also possess previous experience in:Experience working in Quality AssuranceExperience with medical device industryAbout 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 for other accommodation options.