Quality Release Inspector II
The Quality Release Inspector II is responsible for reviewing the documentation of final products to ensure they meet the standards established in the product specifications according to the records captured during the manufacturing process. Their work ensures all products comply with regulatory standards, technical specifications, and safety requirements, contributing to customer satisfaction and company reputation. The Quality Release Inspector II reviews the Device History Records (DHR) to ensure the correct documentation of all processes related to product release. They work closely with production, engineering, and quality control teams to resolve documentation discrepancies and ensure a continuous improvement process.
- Ensure all associated documentation, such as production records, quality records, quality controls and tests, are complete and meet standards, in order to release Finished goods.
- Support the Quality Control department operations in adherence to FDA 21 CFR, ISO 13485, GMPs, and other applicable regulations.
- Support internal and external audits related to product release functions, as well as support root cause investigations or quality figures as appropriate.
- Ensure batch documentation is not tied to any open quality figure (NCMR, Variance, etc)
- Execute batch release in QMS / ERP system as applicable.
- Generate Certificate of Analysis (CoA) for released batches.
- Support projects, ideas, and continuous improvement initiatives focused on their work area.
- Support changes in area procedures and forms.
- Notify the designated supervisor/quality engineer when inspection results exceed acceptable limits and/or report significant quality incidents or inconsistencies in the documentation process.
- Contribute to the certification and training in the DHR Release area.
- Maintain storage of DHR documents.
- Perform other duties as assigned.
Qualifications Knowledge, Skills, and Abilities:
- Proficiency in using PC systems and data packages such as Microsoft Office and Dynamics 365.
- Ability to review and understand written instructions, including blueprints, specifications, and method sheets.
- High attention to detail.
- Experience with development of procedures and forms.
- Experience in control of changes.
- Experience in dealing with process variances and deviations.
- Experience with Non-Conformance events.
- Ability to work under pressure and outside standard working hours.
Working knowledge of FDA 21 CFR, ISO 13485, GMPs, and other applicable regulations.
Work Environment:
- Production/Clean Room/Warehouse/Office environment which may require long periods of sitting, standing, or getting up and down throughout the day.
Occasional lifting up to 35 pounds.
Experience:
2+ years of experience in Quality Assurance or Quality Control.
Education:
Technical Degree in Quality or related field is required.