Senior Quality Engineer, Quality Systems

The primary function of this role is to maintain the Internal Audit System at Cook Ireland (CIRL), and to act as Quality Auditor. The responsible person will also provide technical leadership within Quality Systems to help support all functions on all aspects of the quality management system (QMS) while driving the implementation and improvement of all aspects of the QMS.

Reporting to: Manager, Quality Systems

Find out more about Cook Medical here

• Maintain the Internal Audit System at CIRL acting as the Quality Auditor with a team of Internal Auditors.
• Conduct in-depth Internal Audits of all aspects of the QMS against the relevant regulations.
• Detailed knowledge of the Medical Device regulations, guidance and requirements.
• Ability to implement and improve a QMS.
• Organise and manage site preparation for Regulatory and Corporate Audits.
• Host Regulatory and Corporate Audits.
• Manage Audit back rooms for Regulatory and Corporate Audits.
• Manage the Standards Process ensuring standards are assessed in a timely manner.
• Responsibility for assessing Regulatory Intelligence from a QMS perspective and ensuring compliance is maintained.
• Responsibility for implementing and maintaining Global Good Documentation Practices (GDP) updates as GDP SME.
• Ability to lead QMS Software Validation projects.
• Conduct Supplier audits.
• Ability to lead and drive assigned Process Improvements essential.
• Prepare, implement and analyse key Quality Systems related documentation.
• Ability to lead and progress CAPAs within Quality Assurance.
• Provide input and support to the Cook Medical Corrective and Preventive Action (CAPA) program.
• Provide Quality Systems support to all areas of the QMS, ensuring compliance is maintained at all times.
• Provide training on the Quality Manual and other key Quality Systems procedures.
• Prepare Management Review presentations as appropriate.
• Identify and implement opportunities for improvement and implement under their own initiative.
• Provide mentoring to team members to ensure the effective completion of activities
• associated with their role.
• Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
• Provide inputs to KPI’s and Management Review.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

• Third Level qualification in Science, Engineering or a relevant technical discipline.
• Minimum of 6 years proven knowledge and experience 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.
• Qualified and experienced Lead Auditor, preferably within the Medical Device Industry.
• Strong interpersonal skills with the ability to communicate effectively at all organisational levels.
• The ability to challenge thinking/opinion/actions in light of ensuring Cook Ireland (CIRL) Quality Systems is 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.