Quality Inspector

Role Summary

Quality Inspector (II, III, or Senior) in Quality Assurance. The position reports to Quality Engineering and involves performing incoming inspections of materials/parts/products, reviewing and approving manufacturing batch records and inspection records, and disposition of materials/parts/products. The role also supports Quality Engineering with QMS activities, including environmental monitoring and quality metrics.

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.

Qualifications

• Required: 2-5 years of experience performing inspections and reviews/approvals of manufacturing batch records/inspection records.
• Required: Government Regulated Environment experience such as FDA and ISO 13485.
• Required: Adequate computer experience (knowledge of Microsoft Word, Excel).
• Required: Experience working in a cGMP environment.

Skills

• 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