Quality Inspector
Location: Minneapolis, MN, US
Job Family: Quality Assurance
Country/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 goods Perform 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 coordinator Assist with review and ensure drawings and procedures are up to date Verify 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 required Perform release of raw/incoming materials and finished goods in ERP system Segregate and disposition quarantined and rejected materials (reworks/sorts) and completes necessary documentation; Place material on hold/quarantine in ERP when appropriate Re-inspect quarantined material and process rejected materials (reworks/sorts) and complete necessary documentation Identify any functional problems and work with engineers and operators to resolve production or quality issues Assist production and purchasing with resolution of quality issues regarding incoming or in-process materials Maintain and appropriately file records of testing and sterilization completed Responsible for incoming inspection of tissue bank product Create and provide CoC's for finished goods as requested by sales subsidiaries Conform with Coloplast Q/EHS Policy Coloplast 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 assigned
Basic Qualifications:
Associate's Degree or equivalent related experience required 3+ years of quality inspection experience, preferably in a medical device environment Ability to lift 20 pounds
Required Knowledge, Skills and Abilities:- Knowledge in areas of chemical, physical, and dimensional inspection techniques, equipment, and documentation
- Knowledge of QSR/ISO 13485 requirements preferred
- Ability to read and accurately follow written instructions/documents
- Ability to read and understand drawings, bills of materials, specifications, inspection procedures, and certifications
- Verbal and written communication skills for multi-level company interaction
- Ability to apply mathematical operations to perform audits and incoming inspections
- Working knowledge of Microsoft Office, Trackwise and Lotus Notes systems
- Organized and detail oriented
- Lean and continuous improvement experience preferred
- Good time management skills and the ability to multi-task
- Ability to work under the direction of the senior Quality Inspector
- Employees, work towards working independently, and be self-directed
At 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.
