
Supplier Quality Engineer
3 days ago
**Position Overview**:
**Key Responsibilities**:
- Serve as the **primary supplier quality contact**for Manufacturing Operations, addressing escalations and ensuring timely resolution of SCARs (Supplier Corrective Action Requests).
- Develop and execute **supplier quality improvement strategies**to enhance performance metrics (e.g., KPI, defect reduction) and support high-volume manufacturing.
- Lead **root cause analysis**(8D, 5 Whys, Fishbone) and drive corrective/preventive actions (CAPA) for systemic supplier issues in collaboration with cross-functional teams.
- Conduct **supplier qualifications, audits, and risk assessments**(new/existing suppliers) to ensure compliance with standards such as **ISO 9001, ISO 13485, FDA 21 CFR Part 820, and IATF 16949**.
- Partner with procurement and operations teams to achieve **cost savings**through strategic sourcing, process optimization, and supplier development initiatives.
- Utilize enterprise systems (e.g., **SAP, Oracle, Salesforce, Minitab**) to document and track quality issues, including containment, root cause, and verification.
- Support the development and maintenance of the **Quality Management System (QMS)**and related documentation (e.g., PPAP, APQP, FMEA).
- Communicate supplier performance metrics, project progress, and audit findings to senior leadership.
**Required Skills & Experience**:
- **Education**:Bachelor’s degree in **Mechanical, Manufacturing, or related Engineering fields**.
- **Experience**:5+ years in **supplier quality management**, preferably in **medical devices, semiconductors, electronics, or precision manufacturing**.
- **Technical Skills**:
Expertise in **SCAR, 8D, CAPA, and statistical tools**(SPC, MSA, GD&T).
Proficiency in **quality standards**(ISO 9001, ISO 13485, FDA CFR Part 820, IATF 16949).
Experience with **supplier audits**, **Lean Six Sigma methodologies**, and **process validation**(IQ/OQ/PQ).
Familiarity with **ERP/PLM systems**(SAP, Oracle, SolidWorks) and data analysis tools (Minitab, Power BI).
- **Soft Skills**:Strong negotiation, leadership, and cross-functional collaboration abilities.
**Preferred Qualifications**:
- **Certifications**:ISO Lead Auditor, **Six Sigma Green/Black Belt**, or **ASQ Certified Quality Engineer**.
- Experience in **new supplier onboarding**, **factory setup**, or **cleanroom sterile packaging**(for medical devices).
- Knowledge of **metrology tools**(CMM, VMS) and **CNC machining processes**.
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