Teams at SMC Ltd

Lead quality engineering for medical device new product development: create pFMEAs, control plans, PPAP, validation protocols; analyze FAIRs and validation data; lead CAPA and customer complaints; manage ECOs and quality documentation; support audits, training, and cross-functional continuous improvement to ensure compliance with ISO 13485 and 21 CFR Part 820.

Support product quality and compliance for medical-device manufacturing: perform incoming/in-process/final inspections, testing, DHR/DMR documentation, calibration and metrology activities, validations (IQ/OQ/PQ), statistical studies, root-cause investigations, and supplier CAPA/8D management per ISO 13485/9001.

Ensure supplier quality for medical device components by auditing suppliers, managing supplier classification and CAPAs, supporting PPAP/validation, conducting supplier qualifications (MSA, GD&T, FMEA, FAI), contributing to APQP and validation plans, and collaborating with Procurement, Operations, and Quality to resolve issues and drive continuous improvement.