Supplier Quality Engineer

What you will do:

• Collaborates with suppliers to assure the quality of their products, materials, components and/or operations.
• Analyze supplier performance data and metrics (e.g. DPM, failure modes, trending, etc.)
• Provide input to Sourcing, Site SQEs, and commodity team on supplier performance
• Responsibilities related to Supplier Quality and Change Management, Continuous Improvement, Identify areas of process and system improvement - Propose and implement changes
• Lead Supplier Audit (Must) and preventive CAPA to improve Supplier Quality
• Visit suppliers to resolve issues
• Issue Supplier Corrective Action Requests and ensure suppliers implement robust corrective action which prevent recurrence (CAPA’s)
• Ensure timely and accurate documentation of audit-ready non-conformance records
  

What you will need:

Basic Qualifications:

• Bachelor’s degree in Engineering (Mechanical / Electrical / Electronics / Bio-Medical)
• Minimum of 2-6 years’ experience in Quality / Engineering / Manufacturing environment.
• Good knowledge with GMP, ISO 13485 (Certification), 21 CFR Part 820 standards, FMEA, Validation Programs and SPC processes.
• Demonstrated working knowledge to influence positively the trend of the relevant supplier quality metrics.
• Strong analytical, problem-solving capabilities and communication skills.
• Willing to travel in support of business needs to different geographical locations.
  

Preferred Qualifications:

• Working experience in medical device industry is preferred.
• Lead Quality Auditor Qualification in ISO13485, CFR820 or comparable industry standards and regulatory requirements
• ASQ CQE/CQM/PE certification