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Senior Quality Engineer (QE Systems)

Cook Medical

Limerick, Ireland

Overview

The primary function of this role is to provide Lead and supervise the Quality Engineering group including Quality Engineer(s) and Complaint Investigator(s). Agree objectives, generate training plans, coach team members, carry out performance appraisals and deal with performance related issues. Assess workload for the group and allocate tasks accordingly.

Reporting to: Quality Engineering Manager

Responsibilities

  • Driving all assigned Quality projects and ensuring that they are managed in a structured fashion and completed in compliance with the relevant procedures;
  • Leading in the area of FDA QSR and ISO13485requirements, promoting awareness of best industry practice and making appropriate decisions on a daily basis using the Quality Engineering Manager as the final arbitrator on critical quality decisions;
  • Maintaining a proactive approach to developing Cook’s Quality system to meet the changing needs of the business;
  • Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner;
  • Responsible for Quality systems including the following key processes within the Quality Engineering group:
    • Corrective and Preventive Action program (CAPAs);
    • Non-conforming process, (NCR’s);
    • Customer Complaints.
  • Support of the Internal Audit, Vendor Audit and Regulatory Audit Programmes;
  • Managing quality engineering support to other departments within Cook Medical including Operations and Engineering;
  • Preparation, execution and analysis of related Quality Engineering Documentation;
  • Trending and analysis of key Quality metrics;
  • Responsible for the assessment of risk throughout our key processes and systems;
  • Designee for the Quality Engineering Manager;
  • Ensure that Cook’s Code of Conduct is considered with in all business matters carried out on Cook’s behalf.

Qualifications

  • Third level qualification in Science, Engineering or relevant technical discipline;
  • Proven knowledge and experience (min 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;
  • Previous supervisory experience would be beneficial;
  • Excellent communication and inter-personal skills;
  • Good working knowledge of Microsoft Office;
  • Proven Problem-Solving Skills;
  • Good working knowledge of statistics;
  • Knowledge and experience of all aspects of validation;
  • Excellent organisational and time management skills;
  • Excellent attention to detail;
  • High Self Motivation;
  • Willingness and availability to travel on company business.

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