Cantel Medical

  • Quality System Compliance Specialist

    Location US-MN-Plymouth
    Job ID
    2018-3856
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel ENDO
  • Company Overview

    CANTEL MEDICAL IS A LEADING PROVIDER OF INFECTION PREVENTION PRODUCTS AND SERVICES IN THE HEALTHCARE MARKET, SPECIALIZING IN THE FOLLOWING OPERATING UNITS: 

    ENDOSCOPY

    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.

    WATER PURIFICATION AND FILTRATION

    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.

    HEALTHCARE DISPOSABLES

    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

    The Quality System Compliance Specialist supports compliance of the Cantel Medical Quality System by developing and implementing quality system processes and monitoring quality system compliance under the direction of the Cantel Global Quality System Compliance Director. Collaborate with Cantel Medical divisional QA and RA Leadership and functional teams to ensure substantial compliance to the Cantel quality systems and identifying opportunities for continuous improvement.

    Main Responsibilities

    • Work with Cantel Director Global Quality System Compliance to assure quality systems are in compliance with ISO 13485, FDA QSR Part 820 and other applicable regulatory standards, including support in internal and external audits/inspections.
    • This position interacts with Regulatory Affairs, Quality Assurance, Manufacturing, Engineering, Supply Chain, Research and Development, Sales and Marketing functional leadership.
    • Proactively investigate and support opportunities for the continued development of new quality programs/systems based on direction from Cantel Director Global Quality System Compliance.
    • Facilitate a teamwork atmosphere to urgently resolve compliance issues when they arise.
    • Update job knowledge by keeping abreast of trends and developments in quality assurance, ISO 13485 quality systems, and participating in educational opportunities.

    Qualifications

    • BA or BS degree required, Diploma holder in Life Sciences or Bioengineering
    • Minimum of 2 years Regulatory Affairs and/or Quality Assurance experience in a regulated life science environment
    • Experience in responsibility for compliance to FDA and ISO regulations
    • Must be knowledgeable and able to operate under cGMP, cGLP and ISO 13485 regulations
    • Proficient in computer skills such as MS office programs

     

    Ideal Candidate Profile:

    Personal Characteristics:

    • Strong written and oral skills
    • Strong organizational and management skills
    • Strong problem solving skills
    • Strong attention to detail

    #CB

    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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