Orion

Sourcing Engineer

Jul 2022 - Oct 2024 • 2 yrs 3 mos

Job Responsibilities Proactively search for and screen domestic suppliers based on internal and external requirements, identifying new materials, new processes, and alternative solutions. Independently manage the RFQ (Request for Quotation) process and conduct cost breakdowns of supplier quotations (material costs, processing costs, surface treatment, logistics, etc.). Ensure competitive pricing for each material/component through price comparison, negotiation, and tendering/bidding, and maintain written price comparison records for audit/reference purposes. Lead on-site supplier audits or qualification assessments (quality system, production capacity, delivery performance, financial status), produce assessment reports, and recommend qualified suppliers to management. Lead sample development, testing follow-up, and small-batch validation for new suppliers until materials are formally introduced into mass production. Proactively identify the feasibility of domestic substitution for existing imported materials, and lead the commercial aspects of localization projects (supplier sourcing, sample submission, price negotiation, and introduction). Regularly review the price competitiveness and cooperation level of onboarded suppliers, and initiate re-sourcing or phase-out processes for suppliers that have lost competitiveness.

Manufacturing Engineer

Jun 2015 - Jun 2022 • 7 yrs

Responsibilities: As the key role of project team to handle manufacture engineering related work such as technical evaluation, transform design input to MFG process. Develop new process, define layout out &VSM. Select equipment based on drawing/Spec requirement as well as design fixtures/tooling/jigs and setup new production line。 Lead the process and quality trouble shooting and coordinate cross function team to meet QDIP target Prepare qualification/validation documents (Validation Plan, IQ,OQ, PQ、PFEMA、WI/DHR), complete PV and complete qualification and validation reports. Implement ECR & ECN for product changes and coordinate with related department to make it smoothly. Contact with supplier for related project issues, including cooperate with supplier to contact with tooling plant for tool modification and improvement. Continuously improve the performance (Quality, Delivery, Cost) Maintain part number and BOM, routing in ERP system (SAP). Prepare documents for audits from FDA, CFDA and TUV，BSI…. Technical training for team member Participant and ensure the related QMS & GMP regulatory will be well executed in shop floor. Complete any other duties as assigned by manager