QA Engineer III

Job Title: QA Engineer III Location: Greenville, SC 29611 Duration: 12 Months Shift Hours: 8 AM to 5 PM (Mon - Fri) Job Description: Looking for someone with medical device experience. (anyone from a big med device company) Root cause analysis. Candidate will coordinate with engineering manager as well. Software validation & involved in the design process of medical device. Who is comfortable with Auditing FDA & ISO. Pure manufacturing facility in Greenville, SC. 4 people in Quality team. Roles and Responsibilities: Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma). Qualifications: At least 3 years of experience required. Bachelors required (Science is preferred). Working with CAPA Managing risk management IVDR, ISO 1345, 21CFR 820 need to do. Good at presenting data and willing to work with everyone on the floor for corrective action. They will be coordinating with cross functional teams.