Cantel Medical

Director, Quality Assurance

US-MN-Plymouth
Job ID
2017-3542
# Positions
1
Category
Quality / Regulatory
Cantel ENDO

Company Overview

Cantel Medical is a leading global company dedicated to delivering innovative infection prevention products and services for patients, caregivers, and other healthcare providers which improve outcomes, enhance safety and help save lives. Our products include specialized medical device reprocessing systems for endoscopy and renal dialysis, advanced water purification equipment, sterilants, disinfectants and cleaners, sterility assurance monitoring products for hospitals and dental clinics, disposable infection control products primarily for dental and GI endoscopy markets, dialysate concentrates, hollow fiber membrane filtration and separation products. Additionally, we provide technical service for our products.  

Job Overview

Provide leadership for quality assurance and quality control functions that supports Cantel Endoscopy products and operational processes. Ensure compliance in all quality activities by effectively following applicable quality systems and processes. Facilitate collaboration among Operational groups to maintain quality system compliance, achieve departmental objectives, and sustain continuous improvement. Support strategic objectives by strategically planning and managing Quality Assurance resources.

Main Responsibilities

  • Develop long and short-term plans projecting quality assurance programs and objectives including capital and operating budgets.
  • Lead and develop QA/QC staff located at multiple locations to ensure clear communication, meaningful employee development, and motivation.
  • Maintain clear and open communication between Quality Assurance and other functional leads.
  • Coordinate quality assurance efforts by encouraging a teamwork approach with Operations, Research and Development, Regulatory, Marketing and Sales.
  • Maintain compliance with FDA and ISO requirements, by assuring that all documentation is complete, accurate and complies with FDA QSR 21 and ISO 13485.
  • Be part of the team for facilitating FDA and ISO audits.
  • Collaborate with Cantel’s Quality System Compliance team to improve the quality system and assure suitability with all Cantel Endoscopy products.
  • Proactively investigate opportunities for the continued development of new quality programs.
  • Facilitate a teamwork atmosphere to help resolve complex quality issues when they arise.
  • 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 both career guidance and professional development within the QA organization.
  • Adhere to the cGMP and cGLP guidelines as well as the guidelines established by other regulatory bodies.

Qualifications

BA or BS degree in a technical discipline, with a minimum of 5 years’ experience in a regulated industry is required.  Masters in Business or Field of study preferred.  Must have a sound understanding of how to lead a multi discipline team, located at multiple sites within the United States.  Must have strong problem solving skills and be able to assist the solutions team when quality issues arise.  Strong written and oral skills, together with strong organizational and management skills are a must.   Must be knowledgeable and able to operate under cGMP, cGLP and ISO 13485 regulations.

Minimum Qualifications

Cantel Medical company is an Equal Employment Opportunity/Affirmative Employer. Women, minorities, veterans, and individuals with disabilities as well as other qualified individuals are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin or other protected class status.

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