- At the facility, the company manufactures mainly angioplasty catheters that are used in both coronary and peripheral procedures to unblock arteries.
- We are now recruiting a QA Engineer.
- Reporting to the Quality Manager responsible for Quality Systems, the Quality Engineer will be dedicated to quality system development, and advancement ensuring greater compliance across the facility.
- They will play a key role in the development and execution of plans to ensure compliance to the new MDR regulations and also ensure systems developed will allow for continued compliance to standards as they are revised.
- The role requires a high level of ownership and enthusiasm.
- Review and assess risk management and validation requirements throughout product realisation;
- Perform risk management and validation activities in support of quality system compliance;
- Implement changes in quality management system policies and procedures in line with best practice and systems excellence;
- Effectively communicate with internal and external customers;
- Participate in and support external audit activities;
- Drive CAPA and continuous improvement activities as required;
- Perform internal audits, identify gaps and recommend improvement measures;
- Development of robust action plans, projects and verification activities for prevention of compliance findings across all aspects of the quality system;
- Developing detailed gap analysis and executing plans to maintain compliance to all internal and external standards and procedures;
- Prioritising improvement areas based on risk assessments;
- Systems focus on all key aspects of product realization including R&D, Manufacturing and Logistics activities.
- The successful candidate will have a minimum of 3 years in the medical device or pharmaceutical industry. Knowledge of quality management systems ISO 13485, GMP, etc. The ideal candidate will hold a Third Level Science/Engineering/Technical qualification.
- This includes alignment of the quality system with changes in global and corporate quality management standards, policies and regulations. Assess compliance to global and corporate quality management system standards and regulations including MDR, ISO 13485, CFR 11820 and CMDR.
- You will have excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines. Problem solving techniques with excellent organisational skills & attention to detail and adaptability.
- You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100