Position Overview:
We are seeking an experienced Supplier Quality Engineer to act as the primary quality focal point for manufacturing operations. The ideal candidate will drive supplier quality improvements, resolve escalations, and ensure compliance with industry standards while supporting cost-saving initiatives. The role requires expertise in supplier management, root cause analysis, and quality systems, with a preference for candidates from medical devices, semiconductors, or high-tech manufacturing industries.

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.