Quality Control Clerk
- Perform routine sample collection according to established sampling plans
- Execute sampling procedures consistently across production areas
- Maintain proper chain of custody for all collected samples
- Document sampling activities in compliance with regulatory requirements
- Quality Documentation Review
- Review Device History Records (DHRs), Sterilization History Records (SHRs), and Lot History Records (LHRs) for accuracy and completeness
- Process quality documentation in compliance with regulatory requirements
- Ensure all records are complete, accurate, and properly documented
- Support timely processing to meet production schedules
- Incoming Inspection Activities
- Conduct incoming inspections of materials and components according to established procedures
- Verify incoming materials meet specification requirements
- Document inspection results and maintain inspection records
- Process material acceptance/rejection decisions in ERP system
- ERP/Quality System Transactions
- Execute ERP/Shopfloor transactions related to quality processes
- Update quality system records and maintain data integrity
- Process quality-related transactions to support production flow
- Generate routine quality reports as assigned
- Quality Records Management
- Maintain quality records and documentation systems
- Ensure proper filing and storage of quality documents
- Support document control activities as needed
- Assist with quality system organization and maintenance
- Production Support
- Support routine quality assurance activities across production areas
- Assist with quality clearance processes to minimize production delays
- Coordinate with production teams on quality-related matters
- Provide backup support for other quality assurance processes as needed
- 1-2 years of experience in manufacturing quality assurance
- Previous experience in a regulated manufacturing environment preferred
- Knowledge of quality documentation systems and regulatory requirements
- Familiarity with ERP systems and quality modules
- Basic understanding of statistical sampling techniques
- Understanding of manufacturing quality processes
- Strong attention to detail and record-keeping abilities
- Ability to follow established procedures consistently
- Effective written and verbal communication skills
- Proficient in Microsoft Office applications
- Ability to work independently with minimal supervision
- Working conditions include both office environment and manufacturing floor
- Must be able to sit, stand, and walk throughout most of a shift
- Occasional lifting of materials up to 25 pounds
- Must be detail-oriented and able to concentrate on repetitive tasks
- Ability to work in a fast-paced manufacturing environment
- Maintain documentation processing time targets (1 day average)
- Complete incoming inspections within 12-hour target timeframe
- Achieve 100% compliance with sampling plan execution
- Support reduction in quality-related production delays
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