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The Quality Inspector is responsible for performing and documenting inspections of incoming products, verifying supplier documentation, and supporting internal processes related to product quality and regulatory compliance. This position plays a key role in ensuring that products are released only when they meet all requirements, and that inspection activities are conducted and recorded according to established document and record control procedures and Good Documentation Practices (GDP).
Job Responsibility:
Perform visual inspections of incoming product shipments in accordance with approved inspection plans and work instructions
Review supplier documentation (e.g., Certificates of Conformance, Certificates of Analysis, test reports, sterilization documents, and finished goods inspection records) for completeness and compliance prior to product acceptance
Accurately document inspection results in the Electronic Quality Management System (eQMS) and maintain traceability to lot numbers, purchase orders, and inspection records
General document and record control responsibilities related to product inspections
Identify, segregate, and document nonconforming product per the Control of Nonconforming Product procedure
Maintain and update inspection forms, inspection criteria, and the eQMS inspection module as required
Perform on-site product testing as needed
Notify the Quality Assurance Lead of issues that could impact product compliance, processes, or customer satisfaction
Assist in analysis of returned products and contribute to root cause investigations, Corrective and Preventive Actions (CAPA), and process improvements
Support internal audits and regulatory inspections by providing inspection records and evidence of compliance
Follow Good Documentation Practices (GDP) to maintain accurate, complete, and legible quality records
Analyze inspection data to identify trends and support product improvement initiatives.
Requirements:
High School Diploma or equivalent
technical training or quality certification preferred
1–3 years of experience in product inspection, preferably in a regulated medical device or manufacturing environment, preferred
Familiarity with ISO 13485:2016 and 21 CFR 820 quality system requirements
Proficiency in Microsoft Excel, Outlook, and PowerPoint
experience with electronic quality management systems preferred
Strong written and verbal communication skills, with excellent attention to detail
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