• Responsible to establish, maintain, sustainable, Improvement quality management system compliance with regulatory (NMPA/GMP/FDA), customer, standards (ISO13485/GB/T42061/ISO14971) requirements.• Responsible for Medical product register and manufacturing related to preparation and application. (NMPA-Product Register / Manufacturing License Plan and Application). • Drive and coordinate to quality improvement among in all departs., and supplier based on customer expectation and internal metrics.• Lead quality problem solving and improvement during DV, Design Transfer & Mass Production.• Coordinate to handle quality issues and customer complaint.• Initiate CAPA Plan to the occurrent of NCM product and system deficiency.• Train relevant MD regulatory to employee for enhancement they quality awareness regular.• Ensure compliance ISO, PEC, ESD, MD Regulatory and global requirements.• Assist GM organize MR meeting, lead internal audit, customer audit, 3rd parties, Gov. audit.• Complete special system continuous improvement program from top management assigned.

Responsibility:*Quality Managenent System (Automotive, Aerospace, Communication, General Industry)*Regulations ( Medical)*System Development and Continuous Improvement*QMS Program Management* 5 Core Tool (APQP/PPAP FMEA/ CP/ SPC/ MSA)

Responsibility:*People Management*Quality System Management*Process Continuous Improvement*Supplier Development and Management

Organization team personnel brain storming, wis-dom-collection method, quality record reference previous experiences and knowledge. Ultimately create cause and effective analysis chart for FMEA in accordance with 4M1E and selection suitable advices.Creation quality inspection regulation/process control procedure and surveillance implementation. Drive to deal with quality issue for each manufacturing process of product achievement, and find exceptional quality problem timely during routine inspection which report to manager immediately.Responsibility for import parts and materials inspection for steel plate/pipe/Electrical equipment andWitness commissioning and function testing for electrical.Completion quality guideline/an inspection acceptability per month in according to company quality requirement.Analysis root cause and come up with effective solution and further improvement, when find some quality problems for suppliers and outsources during inspection.TQC inspection Incoming material inspection and witness raw-material retest/machining dimension \welding\ manufacture\ NDT\ ASM\QMS. Instruction and training QC inspectors how to measure correctly machine parts by Measurement tools.In order to improve to product quality, assistance quality manager establish quality improvement planning by measurement \inspection\analysis and improvement process.Implementation regular maintenance and calibrate for instrument /tools /device and measurement gauge for quality department and company.Communication with other departments and general manager/top management and feedback some statistics data analysis of production quality information for company.Maintains effective communication with the customer and relationships with all suppliers, customers and colleagues.Check import components opened package and incoming inspection reference to drawing No& part No. if correspond with standard and have a certification in the crate.shall record and feedback to U.S.

Responsible and accountability description: Review and initial assessment current supplier/ (PSA-Potential Supplier Audit) and ensure that suppliers meet requirement per APQP-Advance product quality planning and PPAP-Production part Approval Process. Inspect and test products and verify relative documentation to ensure compliance with PPAP (Production Part Approval Process). Establish and assure supplier development in accordance with Quality Improvement Plans. Verify and support product and process failure analysis, identify and assure implementation of identified solutions, including priority level of problems involving related manufacturing process. Work with the production Unit to ensure safe on time product delivery, low cost manufacturing and production process and procedure approvals. Statistics manpower amount and production progress and expediting work for daily\weekly.(SPC-Statistics Process Control) Coordinate with the supplier of quality manager/technical manager/production manager and solution all kinds of difficult problems. Coordinate with the owner pay more attention to quality issues , non-conformance report/（NCR）/Outstanding items list/ punch list of project and follow-up action until closed per 8D quality analysis tools. Driving and coordinating to solve complaint for production and quality by customer.Project Achievement  Ignition Switches for Mercedes—Benz Electrically operation seat heater control system for Volkswagen

Responsible and obligation: Review drawings/specifications/ relevant technical requirements and processing modification notice and WPS by the company designer engineer. Incoming materials inspection and checked Heat No. , Specification, type of plate，size, thickness of plate before start to pre-treatment. If found any non-conformance material, shall be marked/hold/ taken photos and feedback to project manager immediately. Responsible for fit up \after welding VT \dimension inspection and assembly\ erection inspection task in the owner field. Witnessing and monitoring welds did ultrasonic testing, checked interior welds if exist defect such as crack (transverse and longitudinal)\ porosity (single& dense)\ slag\incompletely fusion and specified welds did RT (radiographic testing) reference drawing requirement, after arrived time of inspection. Participation safety weekly meeting and actively cooperate with project safety management task. Attend production schedule daily meeting, narration happened quality issue in the field and did not close NCR. Discuss with project production leader and manager how to avoid such as this issue happened again. Quality training task for project production supervisor and management further, in order to improve quality for project. Accompany with the owner inspection finally after structure and mechanical assembly and installation done. Opened Non-conformance report, when owner come up with issue and requirement during inspection. Further tracking follow-up work and closed NCR. Coordinate with production department person modification and close Punchlist from the owner.Project achievement • United kingdom offshore wind power• Korea SAMSUNG 8000T floating crane& vessel• Iran 4400T pipe-laying offshore vessel• New Caledonia steel plant (Australia) • BHP Billiton mooring module for mining industry• The Ron Sheng 900T gantry crane• Italy 3000T pipe-laying offshore vessel • Container crane for international&domestic