Supplier quality engineer

Position's Scope:

Supplier quality engineer will be responsible for overall lmanaging suppliers to comply with global quality  requirements and regulations, supplier qualification, evaluation, auditing and communication.

Responsibilities

  • New supplier selection, classification and qualification.
  • Suppliers
  • Establish and manage an annual supplier quality audit plan.
  • Perform supplier’s audits including corrective actions’ follow-up, and effectiveness where applicable.
  • Maintain approved supplier list within Priority system and signed hardcopies.
  • Define Vendor rating KPIs and establish a rating system that will be presented to quality, purchasing, and operational management in defined time intervals. Define action plans for improvement for low-rating suppliers.
  • Define KPIs and crucial activities supporting quality engineers for Production line transfer processes and qualification.
  • Establish and maintain quality agreements with critical suppliers in compliance with Arineta requirements based on former quality issues and in compliance with notified body and regulation requirements.
  • Ensure suppliers quality of deliverable parts/materials and services.
  • Manage the monitoring of rejected material and supplier corrective action requests follow-up.
  • Drive improvement of Arineta supplier quality processes in Arineta systems.
  • Review and maintain supplier SOPs..

 

Competence and Authority

  • RMA
  • Non-conforming product
  • Supplier Evaluation and Approval
  • Supplier audits
  • Internal audits
  • Suppliers’ agreements and quality agreements

Skills:

  • Deep understanding of quality and regulatory requirements of ISO 13485, 21 CFR p. 820, EU MDR, MDSAP, ISO 14971
  • Strong technical skills
  • Excellent analytical skills
  • Ability to work well in a team environment.
  • Strong problem-solving skills
  • Excellent verbal and written communication skills

Education:

Relevant education in quality CQE/CQM- advantage

Relevant Experience:

  • Familiarity with manufacturing standards and manufacturing processes

    Experience in medical device company

    Experience in Priority.

Advantage Experience:

  • Experience in a similar role

Subordinate to:

QA Director

Languages:

Fluent in English & Hebrew

Comments:

N/A

To apply, send your resume to hr@arineta.com