• Supplier Quality Engineer

    Requisition ID
    2018-4533
    Job Location(s)
    Limerick Ireland
    Languages Required
    English
    Travel
    20-30%
    Company
    Cook Ireland
    Position Type
    Full Time
    Category
    Quality
    Education
    Bachelor's Degree
  • Overview

    The primary function of this role is to provide Quality Engineering support to the monitoring, approval and appraisal of suppliers from a quality perspective. Provide support and guidance to departments liaising with suppliers from an operations, engineering and quality control perspective. This includes, but is not limited to, providing support to process/ supplier validation, change requests, non-conforming product issues, Cook Medical Corrective and Preventive Action program, risk assessment and associated Quality System Documentation.

    Reporting to: Senior Quality Engineer (Engineering)  

    Find out more about Cook Medical here

    Responsibilities

    • Perform supplier quality audits and management of the supplier corrective action process. Maintain and update supplier audit schedule when required.
    • Implement and develop mechanisms to monitor and identify supplier non-conformance trends based on risk.
    • Track supplier quality performance measurements for suppliers (KPI’s) and participate in supplier performance reviews. Completion and approval of supplier evaluations and monitoring when required.
    • Manage and drive continuous improvement activities focusing on supplier quality.
    • Review and support Supplier Change Notifications.
    • Review and approval of raw materials, first part approval and supplier process validations.
    • Maintaining supplier quality documentation in conjunction with purchasing.
    • Liaise with Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control for raw material issues.
    • Provide input and support to the Cook Medical Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process.
    • Support of the Internal Audit, Vendor Audit and Regulatory Audit Programmes.
    • Completion of risk assessment of suppliers, non-conforming materials and CAPA’s.
    • Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
    • Designee to the Senior Quality Engineer.
    • Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

    Qualifications

    • Third Level qualification in Science, Engineering or a relevant technical discipline.
    • Qualification in Quality/Validation/Statistics would be a distinct advantage.
    • Proven knowledge and experience (ideally minimum 4 years) of working with ISO13485, ISO14971, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
    • Qualified Lead Auditor, preferably within the Medical Device Industry desirable.
    • Proven knowledge and experience of all aspects of Validation including Process Validation and design validation.
    • Good working knowledge of statistics.
    • Strong interpersonal skill with the ability to communicate effectively at all organisational levels.
    • The ability to challenge thinking/opinion/actions in light of ensuring Cook Medical Quality Systems and Processes are adhered to.
    • High attention to detail in all aspects of the role.
    • Excellent organisational skills.
    • Proven problem-solving skills.
    • High self motivation.
    • Good working knowledge of Microsoft Office.
    • Willingness and availability to travel on company business.

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