Quality Inspector

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; 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 dispose of quarantined and rejected materials (reworks/sorts) and complete 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 Med Tech Code of Conduct, and company policies.
• Other duties as assigned

• 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

• 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. Here is some of what you can expect:

• Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company-sponsored wellness programs and mental health resources, paid leave of absence for qualifying events.
• Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
• Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life.
• Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture: A supportive work environment where everyone feels valued, and…