Document Control Specialist

7 days ago


Santa Rosa, California, United States SMC Corporation Full time
Job Summary

SMC Corporation is seeking a highly organized and detail-oriented Regulatory Compliance Specialist to join our team. As a key member of our quality department, you will be responsible for ensuring the accuracy and compliance of shipping certifications, quality records, and internal documentation.

Key Responsibilities
  • Shipping Certifications: Prepare and verify all customer required shipping certifications and share them with customers as required.
  • Quality Records: File, scan, and store electronic/hardcopy quality records and packing slips as per customer and/or regulatory requirements.
  • Contract Review: Review Contract Packets and confirm the inspection instructions are correct per P.O.'s and material is correct according to print.
  • Vendor Coordination: Search and print vendor CoC as per customer requirements.
  • Document Control: Create, prepare, issue, maintain, and update production binders and internal documents as needed.
  • Record Management: Store records related to CAPAs, SCARs, CARs into the system and participate in their investigation process as required.
  • Troubleshooting: Troubleshoot material and product traceability issues as appropriate.
  • ECO Process: Coordinate ECO process (Initiation up to release) as needed.
  • Training Database: Maintain training database and scan all training records and work orders; build and maintain library for lot traceability.
Requirements
  • Education: High School Diploma or equivalent.
  • Computer Skills: Basic computer skills and office package (word, excel, PowerPoint, outlook) experience.
  • Language: Ability to read, write, and communicate in English.
  • Adaptability: Adaptability to a dynamic work environment.
  • Teamwork: Teamwork and collaboration.
  • Quality Inspection: Quality inspection experience.
Desirable Qualifications
  • Industry Experience: Experience within the medical device industry.
  • Document Control: Experience in document control processes.
  • Product Release: Product release experience.
ADA Requirements
  • Physical Demands: Typically sits, grasps items, and performs keyboarding for frequent operation of a computer.
  • Physical Activity: Stand, walk, bend, reach, or otherwise move about regularly.
  • Lifting: Lift, move, or otherwise transfer items up to 40 lbs. occasionally, >20 lbs. frequently.
  • Environmental Factors: Occasional exposure to typical machine shop physical hazards.


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