Cantel Medical

  • Sr. Director, Quality Assurance

    Location US-MN-Plymouth
    Job ID
    2017-3542
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    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

    A leadership role for a very successful and growing medical device company, responsible for helping lead the transformation of the QA organization. Provide leadership for design assurance, quality assurance, and quality control functions that supports Cantel Endoscopy and Water Purification and Filtration products and operations. Assure quality and reliable products and processes by establishing and enforcing best in class design assurance practices and quality standards. Maintain compliance in all quality activities by effectively following applicable quality systems and processes. Facilitate collaboration among Operational and New Product Development groups to maintain quality system compliance, achieve departmental objectives, and sustain continuous improvement. Support Organizational objectives by strategically planning and managing Quality Assurance resources.

    Main Responsibilities

    • Develop and manage long and short-term plans projecting quality assurance programs and objectives including key quality metrics, operating and capital budgets, and strategic initiatives.
    • Lead and develop QA/QC staff located at multiple locations, ensuring clear communication, meaningful team member development, and team member motivation.
    • Establish and maintain a supplier quality program.
    • 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 820 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 and Water Purification and Filtration 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 team members within the Quality Assurance team.  Act as a mentor to provide both career guidance and professional development within the QA organization.
    • Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks and/or participating in professional societies.

    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 in a global QA Director or VP leadership position in the medical device industry is required.
    • International experience, specifically continental Europe is preferred.
    • Masters in Business or Field of study preferred.
    • Must have experience leading a multi discipline team, located at multiple sites.
    • Must be knowledgeable and able to operate under cGMP, cGLP and ISO 13485 regulations.
    • Must be knowledgeable and able to operate under a tier 1 ERP systems, such as SAP, and Quality Management Systems, such as Propel.

    IDEAL CANDIDATE PROFILE:

    Leadership Attributes:

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

    Personal Characteristics:

    • Strong written, oral and analytical skills, together with strong organizational and management skills are a must.
    • Must have strong problem solving skills and be able to assist cross-functional teams when quality issues arise.

    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.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed