Supplier Quality Manager

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Location: Irvine, CA US
Job Category: Quality & Regulatory Affairs
Position Description
Supplier Quality Manager

Vyaire Medical is seeking an experienced Supplier Quality Manager for its growing enterprise.  The SQE Manager is responsible for all aspects of the management and improvement of the Vyaire Supplier base.  This includes finished goods and raw material sourcing and supplier Management QA activities for the Specialty Disposables and Capital Businesses to comply with ISO 14971, ISO 13485, FDA 21CFR 820, Council Directive, (European Medical Device Directive) and Canada Medical Devices Regulation, and regulatory requirements to satisfy company objectives.   

Vyaire is looking for an individual that can help build and maintain a high performing supplier quality organization to assure and maintain the design integrity and quality of the products; collaborate on product design improvements including cost reductions and reliability improvements, support the Production and Materials teams at our contract manufacturers, and increase customer satisfaction through continuous product and process improvement, complaint analysis, and identification and implementation of innovative approaches to problems.  This position would report to Director of Global Supplier Development.

In particular you can expect to:  

  • Work with suppliers and manufacturers to perform failure analysis, resolve component problems, including identifying root cause and permanent solutions when necessary.
  • Implementation and administration of quality management systems for activities related with sourcing and supplier management.
  • Reporting of quality trend and information to management on the performance of sourcing-related quality systems.
  • Accountability for quality of sourced products and services.
  • Manage the Supplier Quality Assurance Program (i.e. approval, management, etc.).
  • Design, implement and manage a world-class (benchmark) supplier assurance / supplier certification system.
  • Interact with external compliance authorities and internal assessment groups to demonstrate regulatory compliance and product safety and efficacy.
  • Develop policies, procedures, quality plans, and methods for Specialty Disposables sites to govern sourcing and management activities of branded, private-labeled, and distributed products.
  • Lead the quality effort during launches and modifications of sourced product.  Review Quality Systems of proposed new and existing private label and joint label suppliers / products to verify suppliers /products comply with applicable FDA regulations.
  • Recruit, retain, train, develop, manage, and lead quality personnel.  Provide direction and leadership to direct reports in order to maintain and improve quality operations.
  • Manage spending to the established budget and lead financial initiatives to utilize resources effectively.
  • Other tasks assigned by management.
  • CAPA champion – drives CAPA throughout organization.
  • Support continued compliance with all regulatory requirements and worldwide regulatory authorities, including CFRs, MDD, ISO, FDA, BSI, TUV and others as we continue to expand product distribution and service.
  • Knowledge of statistical methods, Statistical Process Control (SPC) and Design of Experiments (DOE).
  • Perform other work-related duties as assigned.

You will have the opportunity to:

  • Improve patient outcomes
  • Meaningfully impact the company’s short-term and long-term success
  • Work closely with executives across the organization
  • Grow your role as you see fit
  • Learn everything there is to know about respiratory medical device manufacturing
  • Create an inspiring workplace

To be successful, you will need:

  • 7+ years’ relevant professional medical device experience in the following areas:
    • Supplier Quality Management and Regulatory Affairs
    • QSR (21 CFR 820) medical device manufacturing
    • Statistics and sampling methods
  • Demonstrated experience in managing a high-performance team
  • Thorough understanding of validation methods
  • Knowledge of Medical Device Risk Management procedures (ISO 14971)
  • Ability to work independently and effectively in a fast-paced environment.
  • Respiratory Equipment and Device experience is a plus
  • Six-sigma certification a plus
  • Experience in lean manufacturing a plus

Some logistics:

  • Location:  Yorba Linda, CA or Irvine, CA
  • Travel: 25%
  • Physical Demands: May require light physical effort as in periods of prolonged standing, sitting at files or work tables or bending, stooping, or reaching and/or occasional lifting of light items (i.e. up to 30 lbs.). May require some exposure to chemicals used in manufacturing processes.

Irvine, CA

Full time
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