Serosep Ltd.
has 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 ISO13485 and FDA QSR.Handle complaints, non-conformances, CAPA's, investigate root cause of quality issues and follow through with timely and effective corrective action.
Provide Quality Engineering support and understanding of design assurance activities.
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.
Collaborate with operations to develop and implement controls and improvements.
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.
Minimum Qualifications:
Third Level qualification in Science, Engineering or a relevant technical discipline.
Qualification in Quality/Validation/Statistics/Risk would be a distinct advantage.
A minimum of 2 years' experience working with ISO13485, ISO14971.Good working knowledge of Microsoft Office.
Knowledge and experience of all aspects of Validation.
Strong interpersonal skills.
High attention to detail in all aspects of the role.
Excellent organisational and problem-solving skills.
Closing Date:
10th January 2025Apply for position
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