Overview
Quality System Consultant Jobs in San Diego, California, USA at Ardence Consulting
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Business Development & Fulfillment Representative | Pharma | Biotech | Medical Device
(
**** We will not be working with 3rd Party Vendors****)
Quality Systems Consultant
Duration: 3-6 months (Potential for extension)
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 the 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)
Seniority Level:
Mid-Senior level
Employment Type:
Contract
Job Function:
Consulting
Industries:
Medical Equipment Manufacturing
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Title: Quality System Consultant
Company: Ardence Consulting
Location: San Diego, California, USA
Category: Healthcare, Quality Assurance – QA/QC
