Quality System Consultant Job at Ardence Consulting, San Diego, CA

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  • Ardence Consulting
  • San Diego, CA

Job Description

(****We will not be working with 3rd Party Vendors****)

Quality Systems Consultant

Duration: 3-6 months (Potential for extension)

Location: San Diego

Targeted Date: ASAP

Bandwidth: 40 hrs a week

Overview: Our client, an innovative medical device company, is committed to developing devices to improve the lives of patients. They are seeking a consultant to provide support for their UDI quality system.

Key Responsibilities:

  • Oversee the UDI processes for accuracy and compliance with established guidelines
  • Assess, remediate, and optimize the unique device identification quality system
  • Conduct a comprehensive assessment of existing UDI quality system, identifying misalignments and inefficiencies
  • Collaborate with cross-functional teams, including quality, regulatory, IT and supply chain
  • Ensure compliance for regulatory bodies

Technical Requirements:

  • 8+ years of experience in quality systems within medical device industry
  • Strong expertise in UDI requirements
  • Proficiency in QMS and databases
  • ISO 13485
  • Proficiency with electronic quality management systems (eQMS) and UDI data submission platforms (e.g., GUDID, EUDAMED).

Job Tags

Immediate start,

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