Cantel Medical

Quality Assurance Technician

US-CO-Englewood
Job ID
2017-3502
# Positions
1
Category
Quality / Regulatory
Cantel Healthcare Disposables

Company Overview

Crosstex International is a leading global manufacturer of infection control and prevention products for the healthcare market. We create high quality, innovative products, the majority of which are manufactured in the United States. Our broad range of products for multiple healthcare disciplines include: SecureFit® Face Masks, ConFirm® Sterilization Monitoring, SaniTyze™ Waterless Antimicrobial Gel and our Patients Choice ® line of preventive products. With eleven manufacturing/distribution facilities around the world – 7 in the United States and 3 internationally – Crosstex services the global healthcare community in an efficient and timely manner. www.crosstex.com

Job Overview

Maintain the Crosstex, Colorado quality system and associated quality assurance functions. Provide support to Manufacturing Operations by resolving quality related issues, improving product quality delivery, and reporting quality performance metrics. Ensure timely release of components/materials through in process production and finished product inspections to support Manufacturing Operations.

Main Responsibilities

  • Inspects, audits, and reports on components/materials using variable or attribute measuring instruments and techniques to ensure conformance with Crosstex's specifications and quality standards.
  • Identify and document product non-conformances.  Initiate root cause investigations and assist in corrective action development.
  • Maintain data records and files of inspected components/materials.
  • Create and/or maintain documented procedures in accordance with Crosstex Quality System.
  • Inspect and approve all assembly jobs/finished products to confirm assemblies/products meet Crosstex requirements.
  • Evaluate returned items for credit and designate appropriate product dispositions
  • Document, investigate, and resolve product complaints.
  • Look of opportunities to improve materials, processes, and products
  • When necessary provide support to quality activities and projects for other Crosstex locations
  • Perform culture lab auditing functions to include Data Entry and test transfer
  • Maintain compliance with FDA and ISO requirements.
  • Other duties as assigned

Qualifications

  • Must be a high school graduate, with minimum of 2 years quality assurance experience.
  • Must be able to perform basic math functions, possess basic PC skills, such as using Microsoft Word, Microsoft Excel, and able to train on proprietary software.
  • Must be able to read and understand product requirements and sampling techniques as well as safety information.
  • Familiarity with FDA Quality System Regulations, Good Manufacturing Practices, ISO 13485, and Good Laboratory Practices is preferred.
  • This position requires that work be performed in warehouse, office, and controlled environment areas. 
  • Individual must be able to walk, stand, reach both above and below shoulder height, and pull, push or lift up to 50 pounds.  Occasional bending, stooping, and crouching is required.  This position requires frequent repetitive movement of both hands (firm or fine grasping) and good hearing, vision and color distinction.

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