JOB RESPONSIBILITIES
Develop and implement companywide Quality Management System and processes.
Advocate for quality, excellence across the organization.
Responsible for manufacturing quality assurance for incoming, in- process and outgoing quality & test operations. Drive manufacturing and product quality improvements.
Coordinate regular reviews, assessments and internal audits of company management systems.
Establish quality management system and process for manufacturing and production.
Establish Quality control plan for the different manufacturing product lines.
Provide leadership for supplier and customer quality improvement and resolution of quality non- compliances.
Work closely with Manufacturing to develop product QA plans during NPI phase.
Support Procurement team for new supplier qualification, periodic evaluation & ad-hoc audit.
Work closely with Procurement engineer during NPI stage to ensure that procurement engineers have reviewed suppliers' FAI package and part is fully qualified for assembly before taking- over.
Coordinate and lead cross- functional effort in the Material Return Board activities/ programs to resolve the disposition under prescribed lead time for all quarantined materials/parts/components/WIPs/ FGs, rejects/non- conformances, etc., which have been kept on hold.
Coordinate and lead cross- functional effort in the Return Material Authorization and field return analysis.
Analyse supplier capabilities, develop and maintain supplier quality metrics.
Review & follow- up on Supplier's Corrective & Preventive Actions, Performance Rating, 8D.
Coordinate with Supplier on RTV (Return- to - vendor) and part-related field return analysis.
Prepares management report on inhouse/ supplier quality performance.
Coordinate and lead cross- functional effort in the development of Process FMEA in areas of test evaluations, corrective actions execution and implementations, and establishment of documentations & records/ reports.
Lead quality system standards and product regulatory compliance requirements.
Lead IPC-A-160(E), ISO 2859, ISO 9001, ISO 13485, ISO 14001, ISO TS 16949 and cGMP effort and ensure factory compliance.
Interview, hire, supervise, coach and develop Quality Inspector, Quality Technical Operator and Document Controller to achieve desired competencies. Provide mentoring to other junior Quality Engineer.
Ad- hoc duties when assigned.
JOB REQUIREMENTS
Possess at least Degree in Electrical/ Electronics, Mechanical or Quality Assurance Engineering. Master's degree in engineering or quality assurance is an advantage.
Minimum 8 years' experience in Quality Assurance and / or Quality Management System fields with working experience in Quality and/ or Manufacturing environment.
Proficiency in IPC-A-160(E), ISO 2859, ISO 9001, ISO 13485, ISO 14001, ISO TS 16949 and cGMP with solid experience in quality, regulatory affairs and contract manufacturing environments.
Experience in regulatory compliance of UL, CE, CSA, CCC, REACH and RoHS.
Experience in Six Sigma Management program. Six Sigma Green Belt/ Black Belt certifications preferred.
Strong leadership and teamwork attributes.
Excellent communication and interpersonal skills
Knowledge of ERP system is preferable. eg: SAP, IFS & etc.
