Cantel Medical

Quality Engineer

US-TX-Conroe
Job ID
2018-3707
# Positions
1
Category
Quality / Regulatory
Cantel ENDO

Company Overview

Endoscopy procedure disposables include single-use valves and irrigation tubing. Medical device reprocessing systems, disinfectants, detergents and other supplies are used to disinfect high-level endoscopes. 

Job Overview

Provide quality engineering support to Manufacturing Operations by resolving quality related issues, improving product quality, investigating customer complaints and reducing costs. Utilize the MEDIVATORS Correction and Preventive Action system to pursue continuous improvement of the MEDIVATORS Quality System and MEDIVATORS products. Assist with supplier quality support and support cost reduction projects. Participate on Research and Development project teams as needed and support process validations.

Main Responsibilities

• Investigate/analyze customer complaints to monitor customer complaint trends and maintain compliance to MEDIVATORS complaint system.
• Investigate/analyze in-house and field failures (returns) and monitor quality trends. Propose and implement possible solutions/improvements utilizing the MEDIVATORS Corrective and Preventive Action (CAPA) system.
• Initiate supplier corrective actions and assist Purchasing to continuously improve supplier quality and enhance supplier relationships.
• Initiate, review, and approve Engineering Change Orders (ECO), Deviation Authorizations, Qualification/Validation Protocols and Reports, as well as Inspection Procedures.
• Design and/or specify inspection and testing procedures/systems to ensure MEDIVATORS products conform to specifications and quality standards.
• Initiate, review, and approve disposition for Nonconforming Product.
• Support product development teams, including developing or reviewing Quality Plans and Risk Management Plans.
• Support efforts to continuously improve product quality, while ensuring safety, efficacy and regualtroy compliance.
• Suppourt all functional departments to ensure compliance with Medivators’ Quality System and suppourt continuous improvement efforts of the Quality System
• Interface with personnel from all areas of the company to foster improved quality, reduced cost, and process improvement.

Qualifications

• Bachelor’s Degree in Engineering Discipline required
• At least 3-5 years Engineering experience in FDA-regulated industry
• Performance of root cause investigation (use of investigation tools (fishbone, 8D) a plus)
• Must be able to read and understand component/product specifications
• Practical experience/famililarity with ISO 13485 is perferred
• Excellent organization skills
• Excellent attention to detail
• Above average written communication skills
• Ability to work well independently and as part of a team
• Ability to analyze information from regulations, SPC charts, data tables, diagrams, and blueprints
• Ability to prioritize workload, multitask, and meet deadlines 

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