• Knowledge of quality systems 21 CFR 820, ISO 13485, ISO 14971, Six Sigma, TQM.

• Prepare Incoming Inspection Criteria. Ensure that all related inspection and testing activities with regards to the established standards.

• Control inspection materials in both ERP system and physical.

• Maintain record of inspection, testing, equipment calibration, maintenance, etc. per procedures. Scan & archive records in the control system.

• Initiate timely CAPA, SCAR, Non-Conforming Material Processing and follow up

• Perform the Equip/Process Qualifications. Control of Equipment Calibration & Preventive Maintenance.

• Material Issue Investigation Lead, Scrap/NCM Lead, Traceability Lead

Initialize PPAP (Production Part Approval Process) to supplier, gather and maintain all required documentation.

• Maintains PPAP master samples

• Travel to supplier locations to conduct audits and inspections

• Build excellent quality reports.

• Perform other assignments as requested.

• Bachelor’s Degree (BS) at university of technical/scientific fields, with 2+ years of professional experience (experience requirement must be met within a highly regulated industry, such as medical device, pharmaceutical, , automotive, etc…, experience in customer and/or supplier facing quality management/support roles is highly preferred).

• Computer skills required: reference Business Systems & Software Tools above

• Language: must be fluent in English (written & verbal).

• Experience in working with inspection equipment, such as CMM, Optical Comparator and other mechanical measuring devices.

• Technical skills in one of the followings:

• Molded Plastic Parts (including pad/laser print suppliers)

• Gluing, Mating, and Fastening Processes for Enclosures

• Mechanical fastener & chassis components

• Electromechanical connectors & fasteners

• Experience in preparing CpK, PpK, PPAP documentation.

• Strong of reading and understanding technical drawing.

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