Supplier Quality Engineer - Medical Device Background

Katalyst HealthCares & Life Sciences
South Plainfield, NJ
Full-time

Roles and Responsibilities :

  • Collaborate with cross-functional teams to establish quality and performance metrics for suppliers.
  • Establish regular connects with supplier to evaluate Material changes to Parts / Components and decide the implementation actions.
  • Monitor and track supplier performance and provide regular reports to management.
  • Develop and maintain strong relationships with suppliers to ensure effective communication and alignment on quality expectations.
  • Ensure compliance with all applicable regulatory requirements and company quality standards.
  • Represent the company in supplier quality-related meetings and discussions.
  • Proactively identify potential risks and implement risk mitigation strategies.
  • Act as a subject matter expert on supplier quality and provide guidance and support to other departments as needed.
  • Manage Supplier Change Requests and changes relating to supplier improvement initiatives
  • Support supplier quality teams, to establish the processes for : Delivering quality parts, materials, and services, preventing defects.
  • Participate in supplier selection processes to ensure quality requirements are met.
  • Develop and maintain quality standards for suppliers in accordance with industry regulations and company policies.
  • Evaluate and qualify new suppliers through audits and assessments to ensure their capability to meet quality requirements.
  • Excellent organization, Planning, Computer skills, technical writing, Communication skills. MS Office Suite and Outlook.

Must Have :

Minimum of years of relevant experience in Engineering and / or Quality or advanced degree in Engineering, Science, or technical field

Nice to Have :

  • Audit Training (ISO and FDA CFRTraining)
  • PLM Tools : AgileMap, Windchill, SAP
  • PowerBI
  • ASQ CSQP and / or CQE Certificate
  • CAPA Training
  • 30+ days ago
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