The ISO 13485 Medical Device Operator is to effectively fulfill the duties and position for an ISO 13485 Accredited cleanroom. The importance of detailed and accurate documentation for record control is imperative. Medical Device Operators are responsible for making sure processes and outputs meet Total Plastic Solutions LLC. benchmarks. Employees efforts must comply with ISO 13485 Medical Device standard regulations.
1. Handle and inspect small parts and components
2. Clean and disinfect room and equipment
3. Document management
4. Record and track label reconciliation
5. Compliance with CGMP, gowning and clean room environment
6. Must follow detailed instructions continuously
7. Excellent communication skills
8. Appropriate cleanroom attire
9. Must follow proper documentation procedures
10. Must follow safety and quality procedures
11. The ability to work within a team environment
12. Other duties as assigned.
Job Type: Full-time
Pay: From $16 per hour
Benefits:
Schedule:
Ability to commute/relocate:
Shift availability:
Work Location: In person