GENERAL INFORMATION Position Title: | Quality Inspector (II, III, or Senior) | Department: | Quality Assurance | Reports to: | Quality Engineering |
Purpose of the Job This Quality Inspector position will report to Quality Engineering. Main responsibilities include performing incoming inspections of materials/parts/products and reviewing and approval of manufacturing batch records and inspection records. This position will require to perform disposition of materials/parts/products. As a Quality Inspector, you will also support Quality Engineering with other Quality Management System (QMS) activities, such as assisting with environmental monitoring and quality metrics. Major Duties and Responsibilities - Interpret drawings and specification documents.
- Perform incoming inspection of materials/components/subassemblies/finished products following standard operating procedures and using standard inspection tools, including the MicroVu and Keyence.
- Determine inspection sample size based on procedures, specifications, and standards.
- Help develop inspection methods, including automated inspection programs using the MicroVu and Keyence.
- Review/approve executed batch records for manufacturing and inspection records in accordance to QMS procedures and Good Documentation Practices.
- Approve/perform final disposition of materials/components/subassemblies/finished products.
- Assign and apply expiration dating labels to materials/parts/products, as per specifications/quality procedures.
- Initiate Non-Conformance Material Reports (NCMRs) and deviations when discrepancies are observed during inspections and record review process. Report discrepancies and issues to QA Engineering and affected function(s).
- Maintain materials in Quarantine (pending disposition) and MRB (under NCMR and deviations) in order.
- Maintain accurate records as per Document Control procedures.
- Support training of IQC personnel.
- Assist with performing environmental monitoring of Controlled Environment Rooms (CERs), as needed.
- Support Quality in the collection of quality metrics data.
- Interact closely with different functions of the organization.
Education and/or Job Experience - 2-5 years of experience performing inspections and reviews/approvals of manufacturing batch records/inspection records
- Government Regulated Environment experience such as FDA and ISO 13485
- Must have adequate computer experience (knowledge of Microsoft Word, Excel)
- Experience working in a cGMP environment
Skills and Specifications - Attention to detail and organizational skills
- Good interpersonal and communication skills
- Ability to work as a part of a team and promote a team environment
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