Quality Assurance Engineer - Suppliers and Third Party Distributors

Requisition ID
2021-9635
Job Location(s)
Limerick Ireland
Company
Cook Medical Europe Ltd
Position Type
Contract
Category
Quality

Overview

The primary function of this role is to provide Quality Assurance support to the monitoring, approval and appraisal of suppliers and third-party distributors from a quality perspective. Another important aspect of this role is to provide QA support and guidance to departments liaising with suppliers, third-party intermediaries as well as internal stakeholders. This includes, but is not limited to, conducting QA risk assessment activities as part of the selection and approval of third-party distributors, conducting pre-qualification and monitoring audits on suppliers and third-party distributors, drafting and updating Quality System Documentation, preparing change orders, and supporting the Cook Medical Corrective and Preventive Action program.

Responsibilities

  • Provide Quality Assurance support to the Governance, Contracts and Audit function, as well as the Corporate Audit and Supplier Quality team
  • Conduct QA risk assessment activities for suppliers and third-party distributors - both retrospective and prospective.
  • Create a plan for clearly communicating key QA risk assessment criteria to a large population of existing third-party distributors as well as to internal Cook stakeholders, ensuring the receipt of timely responses from these recipients
  • Evaluate third-party distributor and stakeholder responses in order to identify risk, approve or decline from a QA perspective, as well as to assign QA risk classifications to each third-party distributor in a systematic way.
  • Document and archive risk assessment documentation, as well as populating risk classification information on third-party distributor profiles,
  • Conduct pre-qualification and monitoring audits on suppliers and third-party intermediaries, based on risk.
  • Manage and drive continuous improvement activities focusing on quality assurance in the areas or supplier and third-party distributor management.
  • Provide input and support to the Cook Medical Corrective and Preventive Action program (CAPAs)
  • Support any required software validation activities.
  • Support Cook Medical’s Internal Audit program
  • Other job responsibilities as assigned
  • 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, EU Medical Device Regulation 2017/745 and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
  • Knowledge and experience of China’s Good Supply Practice for Medical Devices (GSP) and other regional standards in APAC would be an advantage
  • 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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