Job Description
Quality Assurance Support Role
This is a critical position within Cook Medical Europe Ltd. (CMEU), responsible for ensuring the quality management system (QMS) meets regulatory requirements and company standards.
The Quality Assurance team member will play a key role in maintaining compliance, identifying areas for improvement, and implementing changes to enhance overall QMS performance.
Key Responsibilities
* Oversight of the CMEU QMS: Ensure the quality management system is effective, compliant, and aligned with industry best practices.
* Internal Audit Management: Lead internal audits, maintain the internal audit system, and ensure all aspects of the QMS are audited regularly.
* Regulatory Compliance: Stay up-to-date with medical device regulations, guidance, and requirements relevant to Quality Assurance.
* Process Improvement: Identify opportunities for process improvements and lead initiatives to drive change and enhance QMS efficiency.
* Documentation and Training: Prepare, implement, and analyze key quality systems-related documentation, provide training on the CMEU Quality Manual and other key procedures as required.
* Corrective and Preventive Action (CAPA): Maintain and support the CAPA program, ensuring timely resolution of non-conformances and quality issues.
* Non-Conformance Program: Maintain and support the Non-conformance program, ensuring effective prioritization and resolution of quality issues.
* Delegate Management: Act as delegate for the Manager, Quality Assurance, CMEU, providing support and oversight as needed.
Qualifications and Experience
* Educational Background: Third-level qualification in Quality, Science, Engineering, or other relevant technical discipline.
* Industry Knowledge: Minimum 4 years of experience working with ISO13485, ISO14971, the Medical Device Directive, the FDA QSR, including 21 CFR Part 820 and 21 CFR Part 11, Regulation (EU) 2017/745 (EU MDR), and other Regulations applicable to EMEA regions, preferably in the medical device industry.
* Auditing and Leadership: Qualified and experienced Lead Auditor, preferably within the medical device industry.
* Technical Skills: Good working knowledge of Microsoft Office, desirable.
* Prioritization and Problem-Solving: Strong interpersonal skills, ability to communicate effectively at all organisational levels, and demonstrable ability to challenge and influence thinking/opinion/actions to ensure QMS adherence.
* Attention to Detail and Organisation: High attention to detail, excellent organisational skills, and ability to manage own time effectively.
* Travel and Self-Motivation: Willingness and availability to travel on company business, with high self-motivation, proactive, solution-driven approach to problem-solving.