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Product Quality Labeling Coordinator: 18-00006
Ref No.: 18-00006
Location: Sunnyvale, California
Primary Skills: Understanding of Medical Device QMS and regulatory requirements, documentation
Location: Sunnyvale, CA
Duration: 12 months
Tax Terms: W2 only

Primary function of position
The Product Quality Labeling Coordinator is responsible for reviewing quality records generated during labeling of out-bound product shipments for accuracy and completeness, certifying compliance to destination-required labeling requirements, and updating product device history records (DHRs) accordingly.
The Product Quality Labeling Coordinator is responsible for prioritizing their workload according to the schedules for the Shipping department and the company's global distribution partners.

Major Responsibilities
  • Provides critical documentation to fulfill Regulatory and Import requirements in support of product shipments to global markets
  • Reviews quality records for labeling applied post-manufacturing and updates device history records accordingly
  • Authorizes release of shipments requiring Special Labeling or other post-manufacturing activities
  • Generates Certificates of Conformance and similar documentation for product shipments
  • Works collaboratively with internal customers to resolve quality issues in a timely manner
  • Reports on workload status regularly within the team and identifies issues which pose a potential risk to team goals
  • Performing research for special inquiries into product data (e.g. Date of Manufacture) and providing appropriate documentation to service such requests
  • Performs inventory transactions and ensures that released products are transacted in a timely manner to maintain inventory accuracy for department inventory locations
  • Participates in department process improvement projects or other activities as directed by management
Skill Requirements
  • High school diploma with 2-3 years' work experience or graduate school
  • Exceptional analytical, problem-solving, and root-cause analysis skills
  • Excellent verbal and written communication
  • General familiarity with spreadsheet, word processing, and email software
  • Understanding of, or aptitude to understand, Medical Device QMS and regulatory requirements including, but not limited to, ISO13485 and U.S. FDA 21CFR820
Please apply directly with your updated resume or reach Surbhi at 408-512-2359