Job Description
I am seeking a quality systems engineer for an initial 2-year FTC to join a medical device company at their centre of excellence for manufacturing based in Dublin.
The successful person will be responsible for implementing and maintaining the company's quality management systems in line with standards and regulations.
You will have a degree in science or engineering with a minimum of 5 years' experience working in a medical device or pharmaceutical regulated industry. You will have experience working with established quality systems and experience leading CAPAs and internal audits. You will ideally have qualified internal auditor experience. Technical writing exposure desirable.
Responsibilities:
1. Drive cGMP practices within Operations and Quality divisions
2. Consult with other departments to provide quality oversight to ensure compliance and promote quality improvements
3. Ensure adherence to internal and external regulatory requirements
4. Be an active member of the internal audit team and support external audits at the site
5. Maintain effective implementation of site processes including Change Management, Internal Audits and CAPA
6. Prepare and present data to management on quality system performance
7. Drive thorough investigation & root cause analysis of CAPAs and Internal Audit findings. Support their timely resolution and ensure appropriate actions are taken to prevent recurrence
8. Support process improvement activities
9. Provide a quality review on a range of documentation including procedures, specifications, investigations, GMP records and other Quality Management System documentation as required
If this role is of interest, please apply now or contact me on or on 021 2300 300.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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