Director of Quality Assurance

Cantel Medical   •  

Conroe, TX

Industry: Healthcare

  •  

5 - 7 years

Posted 34 days ago

Company Overview

At Cantel, preventing infection is our business. We are dedicated to delivering high-quality, innovative solutions that help our customers improve patient care. Choosing a career with Cantel means joining a company that's driven by an entrepreneurial spirit and the passion to shape the future of infection prevention. If you want to be inspired by your work and have a hand in shaping the future of infection prevention, we want to meet you. Come and see why people love working here.

Cantel 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. Cantel medical is a leading provider of infection prevention products and services in the healthcare market, specializing in the following operating units:

Medical

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. This segment is operated through MEDIVATORS.

Life Sciences

Water purification systems for dialysis facilities, including hemodialysis dialyzer and reprocessing systems, as well as sterilants and filtration products. This segment is operated through Mar Cor Purification, Inc. and MEDIVATORS.

Dental

Single-use, infection prevention products used primarily in the dental market including face masks, sterilization pouches, towels and bibs, tray covers, saliva ejectors, germicidal wipes, plastic cups and disinfectants. This segment is operated through Crosstex International, Inc.

Job Overview

Provide leadership in quality assurance and quality control functions for all products and processes in the company. Ensure quality in all quality activities by managing the Medivators Quality System.

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.
  • Must be knowledgeable and able to operate under cGMP, cGLP and ISO 13485 regulations. The quality assurance professionals are required to adhere to the guidelines established by the American Society for Quality Control.

IDEAL CANDIDATE PROFILE:

Leadership Attributes:

  • Has the confidence, presence and ability to inspire, influence and motivate people
  • Listens to and values feedback; supports and explains reasoning for decisions
  • Is an effective mentor and coach to team members
  • Respectful of, and actively solicits, team member opinions

Personal Characteristics:

  • Strong written and oral skills, together with strong organizational and management skills are a must.
  • Must have strong problem solving skills

Responsibilities

  • Develop long and short-term plans projecting quality assurance programs and objectives including capital and operating budgets.
  • Lead and develop staff to ensure clear communication, meaningful employee development, and motivation.
  • Coordinate quality assurance efforts in each division of the company by encouraging a teamwork approach with Manufacturing, Research and Development, Regulatory, Marketing and Sales.
  • Responsible for assuring that all documentation is complete and accurate and complies with FDA QSR 21 and ISO 13485.
  • Direct efforts to improve the quality system and assure suitability with all products.
  • Proactively investigate opportunities for the continued development of new quality programs such as GMP training, Lead Auditor Training, etc…
  • Facilitate a teamwork atmosphere to help resolve complex quality issues when they arise.
  • Proactively contribute to the development of the annual budget from a quality functional prospective. Monitor progress against budget and inform upper management of deviations with specific correction recommendations.
  • Provide vision and leadership within and external to areas of responsibility. Contribute to the development of personal within quality.
  • Act as a mentor to provide both career guidance and professional development within the quality organization.
  • Proactively enhance the core technologies by developing quality plans, FMEA, and or test plans for new products. Represent the company at industry meetings. Bring forward emerging developments in the quality field for possible implementation in the company.
  • Maintain compliance with FDA and ISO requirements. This includes being part of the team for FDA and ISO audits.
  • Adhere to the cGMP and cGLP guidelines as well as the guidelines established by other regulatory bodies.
  • Work as a team member with the other members of the QA/RA team to help build and improve the overall quality system.

Minimum Qualifications

Cantel 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. #CB