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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.
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Major Areas of Accountability
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- 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
- Coordinate and support calibration activities - including ensuring equipment is appropriately calibrated and out of calibration issues are properly addressed.
- Maintain and appropriately file records of testing and sterilization completed
- Create and provide CoC's for finished goods as requested by sales subsidiaries
- Conform with and all local Compliance Standards
- Conform with Coloplast Q/EHS Policy
- Other duties as assigned
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Basic Qualifications
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- Associate's Degree or equivalent related experience required
- 5 years of quality inspection experience, preferably in a medical device environment
- Ability to lift 20 pounds
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Knowledge, Skills and Abilities
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- 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
- Strong 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
- Well organized and detail oriented
- Lean and continuous improvement experience preferred
- Good time management skills and the ability to multi-task
- Ability to work 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 worlds 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.
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Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.
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