Quality Inspector

Job description

Supports Value Stream by performing inspections of incoming, in-process and finished goods for implantable medical devices. Responsible for preparation and release of Surgical sterile loads. Ensure documentation and DHRs meet FDA QMSR and ISO 13485 requirements. Major Areas of Accountability: - Perform visual and dimensional inspections of materials including incoming, in-process assemblies and finished goods - Perform product and incoming tests, mechanical and electrical, using equipment including calipers, micrometers, microscopes, visual measurement systems, etc. - Responsible for inspection of electrical components including PCBA boards for visual, continuity, and functional features - Assist with reviewing and ensuring drawings and procedures are current - Responsible for inspection of electrical components including PCBA boards for visual, continuity, and functional features. - Verify production records for completeness and accuracy and records required for inspections, audits, and corrective actions (including device history records (DHRs) and non-conformance reports (NC)) - Prepare and release sterile products; pull pyrogen and bioburden samples as required - Perform releas...