Supplier Quality Engineers

• 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.