Associate Quality Inspector
ColoplastAbout the role
Supports Value Stream by performing inspections of incoming, in-process and finished goods. Responsible for preparation and release of Surgical sterile loads. Ensures documentation and DHRs meet FDA QSR and ISO 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, etc.
- 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
- Effectively 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
- Assist with calibration activities - including ensuring equipment is appropriately calibrated and out of calibration issues are properly addressed.
- Aid in maintaining and appropriately file records of testing and sterilization completed
- Create and provide CoC’s for finished goods as requested by sales subsidiaries
- Conform with Coloplast Code of Conduct and all local Compliance Standards
- Conform with Coloplast Q/EHS Policy
- Other duties as assigned
Basic Qualifications
- High School diploma or equivalent qualification required
- 2+ years of quality inspection experience, preferably in a medical device environment
- Ability to lift 20 pounds
Knowledge, Skills and Abilities
- Knowledge of QSR/ISO 13485 requirements preferred but not required
- 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 required 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
- Well 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 and work towards working independently and be self-directed
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Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.
Visit us on Coloplast.com.
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