Quality Manager – Roscommon
This is an excellent opportunity for an experienced quality professional to join a leading medical device company.
- Implementing an approach of Business Excellence and Continuous Improvement.
- Identify areas for improvement and lead improvement initiatives.
- Championing a structured approach to problem solving within the organisation.
- Facilitate investigation, trouble shooting and reporting on system failures and product defects.
- Ensuring release of product in accordance with approved procedures.
- Maintenance of the plants ISO 13485:2003 / FDA 21 CFR Part 820 compliant Quality System.
- Management of the Quality Assurance Function.
- Management of the plant Corrective and Preventive Action systems.
- Ensuring that products manufactured meet requirements of end users.
- Auditing of the quality system.
- Ensuring that all plant personnel are fully aware of quality requirements.
- Review of customer complaints and device vigilance assessment.
- Management of the company’s validation programme.
- Complete internal and vendor audits to monitor the effectiveness of the quality system.
- Maintaining records in accordance with the quality system requirements.
- Maintaining the plants calibration programmes for test and inspection equipment.
- Change control, deviation and the risk assessment activities associated with these activities.
- BSc. in Quality/Engineering/Science discipline.
- 5+ years People Management experience.
- Experience in the medical device industry and excellent knowledge of ISO 13485:2003, FDA 21 CFR Part 820, and MDD 93/42/EEC
- Ability to simultaneously manage a wide range of diverse activities.
- Desire to own decisions and take responsibility for outcomes.
- Must be commercial, understanding the revenue generating aspects of small business.
- Some travel may be required.
- Must be authorised to work in Ireland.
Please contact Emer Moore to discuss in confidence