Quality Engineer

Quality Engineer Full time, permanent position Reporting to the Quality Manager Serosep Ltd., have a requirement for a quality engineer who will provide ongoing support to maximise production performance and implement corrective/preventative action on all quality issues in production.
You will address any issues identified in the manufacturing process and validation of new processes/products ensuring effective implementation of required QMS documentation.
Main Duties: Lead key elements of quality system to ensure compliance to relevant standards for the business including EN IS013485 and FDA QSR Handling of Complaints, Non-Conformances, CAPAs, investigate root cause of quality issues and following through with timely and effective corrective action Collaborate with cross functional teams to identify opportunities for product/process improvements Analyze data and processes to identify trends and areas for improvement Support the supplier appraisal and approval processes Participate and lead internal and external quality audits Liaise with production and quality control by providing Quality Engineering support Provide quality engineering support to the Serosep quality system.
Initiate, manage and execute projects for continuous improvement within the department.
Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner EssentialCriteria: Third Level qualification in Science, Engineering or a relevant technical discipline.
Qualification in Quality/Validation/Statistics/ Risk would be a distinct advantage.
A minimum 2 years experience working with ISO13485, ISO14971, the IVD / IVDR: In Vitro Diagnostics Regulation and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11 Good working knowledge of Microsoft Office.
Proven knowledge and experience of lean improvement/manufacturing Strong interpersonal skills with the ability to communicate effectively at all organisational levels High attention to detail in all aspects of the role Excellent organisational and problem-solving skills