Internal Audit System Quality Auditor
The primary function of this role is to maintain the Internal Audit System at Cook Ireland (CIRL), and to act as Quality Auditor. This position will also provide technical leadership within Quality Systems to support all functions on quality management system (QMS) aspects, driving implementation and improvement.
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Responsibilities:
* Maintain the Internal Audit System at CIRL as Quality Auditor with a team of Internal Auditors.
* Conduct in-depth Internal Audits of QMS aspects against relevant regulations.
* Detailed knowledge of Medical Device regulations, guidance, and requirements.
* Implement and improve 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 Standards Process ensuring standards are assessed timely.
* Assess Regulatory Intelligence from QMS perspective and ensure compliance.
* Implement and maintain Global Good Documentation Practices (GDP) updates as GDP SME.
* Lead QMS Software Validation projects.
* Conduct Supplier audits.
* Lead and drive assigned Process Improvements.
* Prepare, implement, and analyse key Quality Systems related documentation.
* Lead and progress CAPAs within Quality Assurance.
* Provide Quality Systems support to all areas of QMS, ensuring compliance maintained at all times.
* Provide training on Quality Manual and other key Quality Systems procedures.
* Prepare Management Review presentations.
* Identify and implement opportunities for improvement under own initiative.
* Provide mentoring to team members to ensure effective completion of activities associated with their role.
* Provide meaningful Quality measurement while ensuring in-house or external Quality issues are effectively prioritised and acted upon timely.
* Provide inputs to KPI's and Management Review.
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Qualifications:
* Third Level qualification in Science, Engineering, or relevant technical discipline.
* Minimum 6 years proven knowledge and experience working with ISO13485, ISO14971, Medical Device Directive, EU Medical Device Regulation 2017/745, and FDA QSR including 21 CFR Part 820 and 21 CFR Part 11 ideally gained in medical device industry.
* Qualified and experienced Lead Auditor preferably within Medical Device Industry.
* Strong interpersonal skills with ability to communicate effectively at all organisational levels.
* Ability to challenge thinking/opinion/actions in light of ensuring Cook Ireland (CIRL) Quality Systems 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.