Product Quality Labeling Coordinator

Location: Sunnyvale, CA

Summary:

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.

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 request
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
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
Team-Oriented
Quick Study & Continuous Learner
Perceptive & detailed oriented
Initiative & follow-through
Good judgment
Ethical and independent
Effective Communicator