Hire IT People Inc Senior Supplier Quality Engineer in Lowell, Massachusetts
•Make sure that the supplier has processes in place to ensure all products are biocompatible (i.e., the raw materials are not harmful or contaminated) and collect relevant documents from the Supplier and preserve them in Quality files to maintain EU-MDR standards and ISO 13485 Standards.•Reach out to suppliers, request documentation from suppliers regarding their biocompatibility testing, and create a list to determine the endpoints•Gather supplier information and compile it, and plan together to figure out what testing/studies Zimmer needs to do for everything to be fully compliant to EU MDR standards and fully biocompatible (CAPA, FMEA risk assessment, etc.)•Design, Create, and Close Supplier Corrective Action Reports on Non-conformance that can affect the production of Gastric balloons at customer locations. Scrutinize each SCAR step and follow up with related parties until SCAR is closed with all related evidence attached to it.•Execute Supplier audits along with the Director of Quality to analyze Quality systems related to ISO 9001:2015, Quality procedures, and Standard Operating Procedures of suppliers and review them and send them a detailed report with all recommended changes if needed.•Plan, organize, direct and report on all engineering supplier quality-related activities such as raw materials, contracted designed and manufactured items, packaging materials, service providers, and laboratories to assure procurements meet or exceed the requirements.•Generate Monthly/Quarterly and Annual Supplier Performance Reports for Management visibility•Prepare, maintain, and review procurement quality assurance procedures to assure compliance with customer and/or government requirements.•Ensure that effective up-to-date supplier Quality Assurance documentation, procedures and specifications pertaining to engineering supplier quality are maintained.•Participate in developmental and departmental training•Support Site during external audits (i.e. BSI, FDA, Customer).•Perform other duties as required.