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JOB SUMMARY
Lead and drive integration and sustainability for Global Quality Systems across the Asia region, primarily for Medical Device (ISO13485, FDA, MDSAP, MedAccred) and Automotive (IATF 16949). This position will be located in Penang, Malaysia.
ESSENTIAL DUTIES AND RESPONSIBILITIES Implement and support the set-up of integrated quality systems for Global Quality for the Asia region primarily for Medical Device (ISO13485, FDA, Computer System Validation (CSV), MDSAP, MedAccred) and Automotive (IATF 16949), but will also be accountable for ISO 9001 sustainability for several sites. Lead FDA Inspection readiness and verification activities resulting in zero 483s Support the Regional Site Operations Managers to drive deployment of all regional and global Quality System Initiatives. Create and manage a community of Quality Systems Management across the region ensuring the use of best practices across all areas of Operations. Ensure that metrics (KPI) are accurately and effectively used to assess the continuing suitability, adequacy, and effectiveness of the quality management systems. Ensure that all sites employ the full range of quality systems development and problem-solving tools as required. Drive Global Quality Systems initiatives throughout the region of responsibility. Establish Quality as a competitive advantage. Mentor Site Quality Managers. Ensure quality system objectives are met in the region of responsibility. Create and manage a community of quality systems professionals and Subject Matter Experts. Drive Continuous Improvement Behavior Based Quality mentality across all sites. Provide a path of escalation for all Site Quality/Systems Managers and Quality teams. Work synergistically with other Functional leads across Operations Development Team in region of responsibility. Provide reactive support to individual sites and businesses in the event of quality system issues and escalations. Provide leadership within the Quality Management community of region of responsibility. Provide leadership within the Ops Dev community of region of responsibility. May perform other duties and responsibilities as assigned. JOB QUALIFICATIONS KNOWLEDGE REQUIREMENTS Fluent in English and Mandrin required Excellent leadership and communication skills. Track record showing continual improvement of personal skills. Proficient and knowledgeable in quality management systems. Results-driven change agent. Ability to communicate in all media forms and cross-culturally. Strong analytical and leadership skills. Ability to influence all levels of the organization. Effective communicator Organizationally astute, but not politically motivated. Practices humility and influencing at any level within the organization to achieve goals. Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required. EDUCATION & EXPERIENCE REQUIREMENTS Bachelor's degree in Engineering. Science or Analytical discipline required. Minimum of 7 years of relevant experience. Minimum of 5 years in SMT, Machining, Tooling, and Plastics manufacturing experience 5 years of experience in management in a heavily matrixed environment. Proven experience in establishing FDA Inspection readiness and front room participation in multiple FDA Inspections Proven experience implementing and sustaining Quality Management Systems for ISO13485, IATF16949, and ISO 9001 Demonstrated knowledge of participating in Computer System Validations Proven Certified Six Sigma Black Belt preferred. Experienced in successfully leading the Quality System function in a multi-cultural and multi-site environment. Experience as a Quality Manager / QMS Manager in high volume, high mix industries. Proven experience in developing and maintaining FMEAs and Control Plans Or a combination of education, experience and/or training. 25% travel required, domestic and international Compensation Grade: M04
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