Crosstex International, Inc. QA Technician in Rochester, New York
Who we are
At Cantel, preventing infection is our business. As a leading provider of infection prevention products and services in the healthcare market, we are dedicated to delivering high-quality, innovative solutions that improve outcomes and help save lives. We accomplish this mission by delivering our products through the following operating units:
Medical : Endoscopy procedure disposables include single-use valves and irrigation tubing. The medical device reprocessing systems, disinfectants, detergents we manufacture and distribute are used to disinfect high-level endoscopes.
Life Sciences : Water purification systems for dialysis facilities. We work with leading dialysis caregivers, delivering hemodialysis dialyzers and reprocessing systems, as well as sterilants and filtration products.
Dental: Single-use, infection prevention products used primarily in the dental market (face masks, sterilization pouches, towels and bibs, tray covers, saliva ejectors, germicidal wipes, plastic cups and disinfectants).
Cantel employees are inspired to improve the lives of patients, caregivers and healthcare providers. If you are looking for a company driven by an entrepreneurial spirit and have the passion to shape the future of infection prevention, we want to meet you. Join us and see why people love working here.
About the role
Support the 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. #CB
What you will do
- 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.
- Perform incoming material, in-process, and finished good inspections.
- Maintain data records and batch files of inspected components and materials.
- Identify, document, and report product non-conformances.
- Provide feedback to Operations through reportable metrics and daily collaborative dialogue
- When necessary provide support to quality activities and projects for other Crosstex locations
- Look for opportunities to improve materials, processes, and products.
- Maintain compliance with FDA, ISO, and other applicable regulatory body requirements.
- Other duties as assigned.
What we are looking for
- Must be a high school graduate, with minimum of 2 years' quality assurance experience or equivalent experience within a manufacturing or medical environment
- Must possess intermediate PC skills, such as using Microsoft Word and Microsoft Excel.
- Must be able to read and understand product requirements. Experience with sampling techniques and safety information preferred.
- Must have strong oral and written communication skills while working within a dynamic crossfunctional team
- 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.
- Familiarity with document control and root cause investigations is preferred.
- Understanding of audit processes and etiquette.
- 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.