Quality Control Specialist
7 days ago
Key Responsibilities:
- Perform routine and special inspections for visual, dimension, and functional assessments, ensuring adherence to inspection instructions.
- Document and report inspection findings, monitoring corrective actions for any identified issues.
- Execute product identification and traceability activities as required.
- Review, approve, and maintain Device History Records for all manufacturing functions, in compliance with relevant standards and regulations.
- Apply in-depth knowledge of QSRs/ISO and regulatory guidelines to daily tasks, ensuring quality standards are upheld.
- Monitor and comply with customer specifications and company quality assurance policies.
- Ensure proper calibration and maintenance of inspection equipment.
- Conduct and document hourly inspections.
- Perform and document line clearance procedures.
- Carry out First Articles and Retention Samples, documenting and filing accordingly.
- Review, approve, and file documents for completeness and compliance.
- Minimum 6 months of Quality Control inspection experience required.
- Experience with Good Manufacturing Practice (GMP)
- Experience in a medical device high-volume manufacturing environment is strongly desired.
- Ability to read, interpret, and follow detailed procedures, instructions, and drawings.
- Solid understanding of QSRs/ISO standards.
- Demonstrated team-oriented interaction skills and professional behavior.
- Proficiency in word processing, data entry, and spreadsheet navigation.
- Familiarity with basic quality terms, definitions, and concepts.
- Understanding of traceability (product, material, and calibration).
- Basic math skills for determining appropriate sample sizes for inspection based on lot sizes.
- Problem-solving skills to identify processes and standards in need of improvement and initiate appropriate action.
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