Quality Inspector

Quality InspectorLocation: Minneapolis, MN, USJob Family: Quality AssuranceCountry/Region: United StatesJob Function Summary: Supports Value Stream by performing inspections of incoming, in-process and finished goods. 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 goodsPerform product and incoming tests, using equipment including calipers, micrometers, microscopes, visual measurement systems, etc.Assist calibration system; including ensuring equipment is appropriately calibrated and out of calibration issues are properly addressed as a calibration coordinatorAssist with review and ensure drawings and procedures are up to dateVerify production records for completeness and accuracy and records required for inspections, audits, and corrective actions (including device history records and non-conformance reports)Prepare and release sterile product; pull pyrogen and bioburden samples as requiredPerform release of raw/incoming materials and finished goods in ERP systemSegregate and disposition quarantined and rejected materials (reworks/sorts) and completes necessary documentation; Place material on hold/quarantine in ERP when appropriateRe-inspect quarantined material and process rejected materials (reworks/sorts) and complete necessary documentationIdentify any functional problems and work with engineers and operators to resolve production or quality issuesAssist production and purchasing with resolution of quality issues regarding incoming or in-process materialsMaintain and appropriately file records of testing and sterilization completedResponsible for incoming inspection of tissue bank productCreate and provide CoC's for finished goods as requested by sales subsidiariesConform with Coloplast Q/EHS PolicyColoplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies.Other duties as assignedBasic Qualifications:Associate's Degree or equivalent related experience required3+ years of quality inspection experience, preferably in a medical device environmentAbility to lift 20 poundsRequired Knowledge, Skills and Abilities:Knowledge in areas of chemical, physical, and dimensional inspection techniques, equipment, and documentationKnowledge of QSR/ISO 13485 requirements preferredAbility to read and accurately follow written instructions/documentsAbility to read and understand drawings, bills of materials, specifications, inspection procedures, and certificationsVerbal and written communication skills for multi-level company interactionAbility to apply mathematical operations to perform audits and incoming inspectionsWorking knowledge of Microsoft Office, Trackwise and Lotus Notes systemsOrganized and detail orientedLean and continuous improvement experience preferredGood time management skills and the ability to multi-taskAbility to work under the direction of the senior Quality InspectorEmployees, work towards working independently, and be self-directedAt Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance.