Cantel Medical

  • Sr Supplier Quality Engineer

    Location US-MN-Plymouth
    Job ID
    2019-5249
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel Medical
  • 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.

    #CB

    Job Overview

    We are seeking a seasoned Supplier Quality Engineer to join our Medical Division products manufactured in Plymouth, MN. This position will provide Supplier Quality expertise and establish best practice supplier quality processes in support of New Product Development, Manufacturing Operations, and Customer Quality. If you are looking for your next career step with the opportunity to work with diverse cross-functional groups and suppliers while improving patient lives we would like to hear from you.

    Main Responsibilities

    • Effectively partner with suppliers to ensure products conform to specifications and quality standards while driving continuous improvement with vendors.
    • Develop partnerships with Supply Chain, R&D, Design Assurance, Sustaining Engineering, Technical Services and Manufacturing groups.
    • Support the Material Review Board (MRB) process and lead the investigation, resolution, and prevention of supplied component non-conformances.
    • Lead the supplier corrective action process (SCAR) to address manufacturing and customer complaints and improve product quality.
    • Monitor and manage risk in supply chain through the vendor approval process, potential new supplier assessments, supplier quality system audits, supplier performance monitoring, and qualification of purchased product.
    • Prepare and negotiate Quality Agreements with Suppliers.
    • Review and approve Engineering Change Orders (ECO), Deviation Authorizations, Qualification/Validation Protocols, First Article Inspection Reports, and Receiving Inspection Procedures related to purchased product.
    • Communicate supplier quality metrics and status of corrective actions and projects to Operations team and multiple levels of Leadership.
    • Recommend and drive continuous improvements in the Supplier Quality organization to improve systems and processes.
    • Travel to supplier locations up to approximately 10%.

    Qualifications

    • BS in Engineering (or equivalent)
    • Minimum of 7 years engineering work experience in a Quality function with at least 3 in Supplier Quality function.
    • Experience/familiarity with regulated product quality system requirements, i.e. ISO 13485, FDA Quality System Regulations, ISO 14971, and other applicable standards.
    • Experience with supplier quality systems and processes including Supplier Corrective Actions (SCAR), Production Part Approval (PPAP), First Article Inspection (FAI), Supplier Quality Agreements, Supplier Audits, Supplier Transitions, and Product Change Notifications.

    • Practical knowledge and experience in statistical analysis, problem-solving, process improvement techniques, Corrective and Preventive Action, Quality Plans, PFMEA, and manufacturing process validation.
    • Must be able to read and understand component/product specifications. GD&T knowledge desirable.
    • Familiarity with a variety of components and manufacturing processes including electro-mechanical components, valves, pumps, circuit boards, electrical harnesses, metal fabrication, and plastic molding desirable.
    • Must have competent PC skills and be proficient with Microsoft Word and PowerPoint. Advanced level skills in Excel required. Experience using Minitab statistical software is desirable.
    • Experience writing standard operating procedures and work instructions, implementing new processes, and training employees or suppliers accordingly.
    • ASQ Lead Auditor certification or equivalent desirable.

    • Self-starter with the ability to quickly learn about new processes, products, and projects
    • Work effectively with cross-functional teams with the ability to leverage or engage others to accomplish tasks
    • Ability to build strong working relationships within the organization and partnerships with suppliers.
    • Strong verbal and written communication skills, including the ability to write technical reports/presentations and to negotiate Supplier Quality Agreements
    • Solid organizational and follow-up skills, as well as attention to detail
    • Critical thinker with analytical problem-solving skills with the drive to resolve quality related issues in a timely and effective manner
    • Strong presentation skills and able to effectively communicate with higher levels of management

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