Cantel Medical

Director Quality Assurance

US-NY-Rochester
Job ID
2017-3461
# 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

Provide leadership for Crosstex Quality Assurance and Quality Control functions that supports Crosstex products and operational processes. Ensure compliance in all quality activities by managing the Crosstex Quality Systems. Facilitate collaboration among Operational groups to maintain quality system compliance, achieve company and departmental objectives, and sustain continuous improvement. Support Crosstex strategic objectives by strategically planning and managing Quality Assurance resources.

Main Responsibilities

  • Provide vision and leadership within and external to areas of responsibility. Contribute to the development of personal within the Quality Assurance team.  Act as a mentor to provide motivation, career guidance and professional development within the QA organization
  • Maintain clear and open communication between Quality Assurance and other functional leads.
  • Develop long and short-term plans projecting quality assurance plans, programs and objectives, including capital and operating budgets.
  • Maintain compliance with FDA and ISO requirements.  This includes being part of the team for FDA and ISO audits.
  • Coordinate quality assurance efforts by encouraging a teamwork approach with Operations, Research and Development, Regulatory, Marketing and Sales and facilitate an atmosphere of prompt resolution to issues when they arise.
  • Work collaboratively with Cantel Director of Global Quality System Compliance and Functional leaders to ensure adherence of Crosstex Quality Systems.
  • Direct cross-functional efforts to improve the quality system and assure suitability with all products.
  • Organize and schedule Quality Management Reviews as required by the Quality System.
  • Participate in Crosstex Leadership meetings. 

 

Qualifications

  • BA or BS degree in a technical discipline, with a minimum of 7 years’ experience in the medical device industry is required. 
  • Masters in Business or Field of study preferred.
  • Background in sterilization or healthcare disposables preferred.
  • Must have a sound understanding of how to lead a multi discipline team. 
  • Must have a sound understanding of manufacturing operations.
  • Must have strong problem solving skills.
  • Strong written and oral skills, together with strong organizational and management skills are a must.
  • Must be knowledgeable and able to operate under FDA Part 820, ISO 13485 and cGMP, cGLP regulations.
  • Responsive and reliable, with exceptional follow-through.
  • Ability to work both independently and as a team player.

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