SQE 供应商质量管理工程师

该职位来源于猎聘 职位概要(Job Summary)

Responsible for ensuring that externally sourced materials, components, and services meet the company’s quality standards and regulatory requirements for medical device manufacturing. The SQE will partner closely with suppliers, engineering, manufacturing, procurement teams and customers (as applicable) to drive supplier performance, resolve quality issues, and ensure compliance with applicable regulatory standards including ISO 13485, FDA 21 CFR Part 820, and applicable international regulations. This role plays a key part in supplier qualification, supplier performance monitoring, supplier development, and supplier corrective actions, ensuring a robust and reliable supply chain that supports product quality and patient safety. 工作职责(Responsibilities): Supplier Qualification &

• Approval

• Lead supplier selection, qualification, and onboarding activities including supplier audits, capability assessments, and risk evaluations.
• Ensure suppliers comply with ISO 13485, FDA QSR, and internal quality system requirements.
• Participate in supplier risk assessments and supplier classification activities.

  Supplier Performance

  Management

• Monitor and analyze supplier quality performance metrics such as LAR, complaint rates, and corrective action effectiveness.
• Participate in regular supplier business reviews to drive continuous improvement and performance alignment.
• Maintain approved supplier list (ASL) and supplier quality records.

  Supplier

  Audits

• Plan and execute supplier quality system audits along with Global Supplier Quality.
• Ensure closure of audit findings and verify effectiveness of corrective actions.

  Supplier Corrective

  Actions

• Lead and manage Supplier Corrective Action Requests (SCAR).
• Investigate supplier-related nonconformances using structured problem-solving methodologies such as 8D, Root Cause Analysis, and CAPA.
• Ensure timely implementation and effectiveness verification of corrective actions.

  Incoming

  Quality &

  • Material Controls

• Collaborate with incoming inspection teams to define inspection plans, sampling strategies, and acceptance criteria.
• Support disposition of nonconforming materials and supplier-related deviations at incoming and production level.

  New Product

  Introduction (NPI)

• Support supplier qualification and readiness during new product introduction (NPI).
• Review and approve supplier process validations, FAI reports, and capability studies.
• Ensure supplier compliance with design transfer and manufacturing requirements.

  Supplier

  Development

• Drive supplier improvement initiatives including process capability improvements, yield improvement, and defect reduction programs.
• Provide technical support to suppliers to enhance manufacturing processes and quality systems. Regulatory &
  • Compliance

• Ensure supplier processes and documentation comply with applicable regulatory requirements.
• Support internal audits, external audits, and regulatory inspections involving supplier quality 任职资格(Qualification) : Education:

A bachelor’s degree in Engineering, Life Sciences, Mechanical Engineering, Electronics, Biomedical Engineering, Materials Science, or a closely related science or engineering field is preferred.

Experience: 1. 3~5 years in Quality Assurance, with at least 2 years in a Supplier Quality role.

• Strong experience in supplier quality management in a medical device or other regulated industry, working experience in a medical device company is preferred
• Certified Quality Auditor ISO 13485 or ISO 9001(ISO 13485 is preferred) Skills &
  • Competencies:

• Excellent communication, negotiation, and interpersonal skills, Good English listening, speaking, reading and writing skills.
• Proficient in quality tools: root cause analysis, 8D, FMEA, SPC, PPAP, etc.
• Proficient in the auditing process and techniques of suppliers.
• Proficient in the change control process of suppliers and knowledge of Validation.
• Ability to manage multiple priorities and cross-functional projects in a fast-paced environment.
• Six Sigma Green/Black Belt priority consideration.
• Rich experience in managing overseas suppliers is preferred.