Position Title
Director Quality Assurance North America
SBU
Corporate
Department
Quality Assurance
Relocation Covered
YES
Educational Requirements
Bachelor's degree
Experience Requirements
A minimum of 10 years experience in the medical device industry in quality assurance functions commensurate with the responsibilities outlined above. A minimum of 8 years managing quality assurance resources. Extensive knowledge and understanding of US and European medical device regulations. Extensive knowledge and understanding of US and international medical device standards and guidance documents including FDA, ISO. PAL, MDD and CMDR. Extensive knowledge of ASQ, ANSI, AAMI and ASTM standards and guidance documents.
Qualification Requirements
Extensive knowledge of sampling plans, inspection criteria and techniques, critical attributes, process validations, statistical methods, disposition of non-conforming product, trending methods, environmental monitoring. Experience and knowledge of lean manufacturing, six sigma and cost of quality tools and techniques. Experience and knowledge of design of experiments and other failure investigation methods. Experience with regulatory inspections/audits, specifically FDA and ISO Inspectors. Experience performing internal and external audits. Knowledge and experience with corrective and preventive actions systems. Knowledge and experience with statistical process control, defects-per-million, and other process monitoring methods and techniques.
Preferred Qualifications
Provides leadership to overall CAPA process for all North America Teleflex Medical and Arrow International facilities. Ensure CAPA process is executed in a timely and thorough manner in all North America Teleflex medical and Arrow International facilities. Manage the CAPA brand for Arrow International facilities and ensure that the appropriate resources are applied to projects. Ensure that all inputs to CAPA are captured and that these potential issues are addressed by the CAPA system across facilities. Working with all the North American facilities to ensure that investigations are thorough and documented appropriately. Participate in management reviews to discuss CAPA issues.
Responsibilities
Provides leadership to overall CAPA process for all North America Teleflex Medical and Arrow International facilities. Ensure CAPA process is executed in a timely and thorough manner in all North America Teleflex medical and Arrow International facilities. Manage the CAPA brand for Arrow International facilities and ensure that the appropriate resources are applied to projects. Ensure that all inputs to CAPA are captured and that these potential issues are addressed by the CAPA system across facilities. Working with all the North American facilities to ensure that investigations are thorough and documented appropriately. Participate in management reviews to discuss CAPA issues. Position requires direct contact with Implantable Device
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