QA Engineer

• Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services
• Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems
• Experience with PCBA suppliers and validation of PCBA test and manufacturing processes strongly preferred
• Develop and prioritize an auditing schedule to ensure suppliers meet GMP and quality standards through regular audits
• Evaluate suppliers' internal functions to assess overall performance and provide feedback
• Manage Non-Conformance Material Reports (NCMRs) on materials-related quality issues and trends (Incoming, Production, Sterilization)
• Handle suppliers' change requests, including communication, project management via MAP Agile workflow, and regular reporting
• Manage the Approved Supplier List, including administrative work in MAP Agile
• Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management
• Improve suppliers' performance and reduce escapes to manufacturing
• Execute Process validation IQ/OQ/PQ and Master Validation Planning in new product development
• Knowledgeable in Statistical analysis (MSA, Capability, SPC)
• Support DFMEA and PFMEA activities Identification of critical to quality parameters and process controls in collaboration with designers and cross-functional team
• Design Transfer; translating design specifications into production specifications
• Use project management skills to ensure that supplier processes are developing at the appropriate cadence to support engineering builds and Design Verification and Validation
• Provide mentorship and coaching

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