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Supplier Quality Auditor : 18-00130
Ref No.: 18-00130
Location: Sunnyvale, California
Primary Skills : Quality Assurance, SCAR, Audit, 21 CFR part 820 and ISO 13485, Supplier Quality, Compliance
Duration : 3-6 Months
Contract Type : W2

 
Description : 
Joining Our Client means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
 
Roles and Responsibilities :
  • This position has responsibility and authority to:
  • Ensure Suppliers conform to Quality System requirements.
  • Ensure compliance to quality management system and regulatory requirements by planning, leading, and executing supplier evaluation audits.
  • Write and issue audit reports.
  • Ensure suppliers effectively resolve audit related SCARs in a timely manner.
 Skill/Job Requirements :
  • In order to perform the responsibilities of this position the individual must possess:
  • BS degree in Engineering or equivalent
  • Minimum 10 years related experience in Supplier Quality, Quality Assurance, Compliance, or related field
  • Excellent knowledge of 21 CFR part 820 and ISO 13485
  • Experience auditing suppliers to the above mentioned standards as a lead auditor
  • Third party lead auditor certification preferred
  • Excellent written and verbal communication skills
  • Proficiency with Windows, Word, and Excel
  • Experience in a high-volume medical device company is a plus
  • Ability to travel to suppliers on an as needed basis – domestic and international

    Please apply Directly with you updated resume or call Pankaj @ 408-512-2356