Job
Description
Implement Quality Engineering, Purchasing Controls, and Supplier Quality processes related to the development, procurement, and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices, products, or services. Evaluate suppliers critical quality processes and ensure compliance with regulatory requirements and procedures. Drive supplier improvement via SQIPs (Supplier Quality Improvement Plans) and lead the Supplier Change Notice process with support from Engineering, Quality Engineering, Assurance, Qualify suppliers, assess their metrics, and audit their critical quality processes. Ensure validations are completed where specified and control plans exist to ensure sustained quality and compliance of supplied raw materials and components. Independently Produces and completes Supplier Quality Engineering related activities and documentation. Completes Qualification of materials and components (including spare parts), development/ improvement of supplier processes for CtQ's, supplier process control plans; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met. Qualifies and sustains sub- processes of suppliers, including performing process validations for critical supplier processes impacting part quality. Ensures that the components/products at the supplier (including spare parts and services) are released according agreed specification and quality requirements (APQP / PPAP), and SQ audit results. Executes SCAR management, effective and timely closure Regulatory, ME, R&D, Clinical, etc. Experience in leading process improvement methodologies and organizational change management. Proven record of accomplishment in developing suppliers and implementing lean methodologies at supplier end. Develop and support regulatory compliance gaps at suppliers, including supplier quality system and process development activities. Manage additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records Ensure raw materials/components/products at supplier(s) are released from supplier(s) according to the agreed requirements. Perform 3rd party product compatibility risk assessments in partnership with R&D and Market Procurement (Markets SQE). Drive quality and compliance development and/or improvement at suppliers when needed. Required Skills and Qualifications: Bachelor's degree in engineering or science discipline, or equivalent experience. A minimum of up to 4 years of experience in establishing and maintaining regulated supplier management systems. Experience with APQP (IQ,OQ,PQ) preferred. Technical writing of protocols and reports. Experience in ISO 9001, 13485 a plus. Engineer quality and ensure compliance for raw materials, components, finished products etc. Certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer(CQE) and Certified Quality will be advantage. Any Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course will be added advantage. Excellent communication skills in English (written and verbal). Demonstrated experience in collaborative working environments, conflict resolution, and stakeholder influencing. Ability to drive progress, take initiative, and achieve results. Experience with technical drawings, specifications of parts. Experience in Manufacturing process of welding, soldering, crimping, injection molding, plating, casting, and thermal forming Effective communication skills in Mandarin and English. Ability to travel to supplier sites within assigned region. Ability to speak and communicate with local suppliers in native language (Mandarin) and in English.
