Our client, a medical device company in Shannon are currently looking to recruit a Quality Systems Engineer II
for their site.
To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.
- Demonstrate a primary commitment to patient safety and product quality.
- Responsible for the generation of quality reports/metrics on a monthly basis and coordinating the Management Review slide deck on a quarterly basis
- Facilitates LBP related projects implementing efficiency improvements in Quality Department on a continuous basis and participating in site projects and initiatives.
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Participates on Quality System CoPs and co-ordinates on-site Monthly review for CoPs with all CoP leads
- Support the preparation of documentation for regulatory submissions
- Oversight of the Doc Issuance process on site and act as Cork liaison with Galway/Corporate Doc control for assigning Document Owners and ensuring Annual documentation review is completed on time
- Oversight of CI board for Quality systems and VIP activities for Quality department
- Support of backroom audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
- Provide quality support and guidance to infrastructure teams such as facilities and equipment engineering on quality related issues including NCEP & CAPA.
- IRB: Review of IRB trends and identification of appropriate corrective actions when required.
- Support Global QMP's as applicable for the site and the implementation of quality system changes under EU MDR
- Minimum of Bachelor of Science Degree in Engineering/Technology
- 2/3 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
- Experience in the medical device industry is an advantage.
For further information on this Quality System Engineer II role in Cork please contact Orla on 086 0449473 / firstname.lastname@example.org
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