Description

You will own the implementation and maintenance of quality engineering, purchasing controls, and supplier quality processes for manufacturing materials, components, and services.

Responsibilities

• Evaluate supplier critical quality processes to ensure compliance with regulatory requirements.
• Drive supplier improvement through Supplier Quality Improvement Plans (SQIPs) and manage the Supplier Change Notice process.
• Qualify and sustain supplier sub-processes, including performing validations for critical supplier processes.
• Manage the Approved Supplier List, controlling additions, deletions, and status changes.
• Execute Supplier Corrective Action Request (SCAR) management and ensure timely closure of regulatory issues.

Required Skills

• Bachelor's degree in engineering or science discipline or equivalent experience.
• Minimum of 4 to 8 years establishing and maintaining regulated supplier management systems.
• Experience engineering quality and ensuring compliance for raw materials, components, and finished products.
• Demonstrated experience in process improvement methodologies and organizational change management.
• Experience with technical drawings and part specifications.
• Familiarity with manufacturing processes such as welding, soldering, crimping, injection molding, or plating.
• Experience in ISO 9001 or ISO 13485 environments.
• Excellent written and verbal communication skills in English.
• Ability to travel to supplier sites within the assigned region.

Key Skills

Education

Bachelor's degree