- You will work as part of the projects department on enhancing existing processes and systems to improve product quality and lifecycle but also on adherence to regulatory compliance.
- Work closely on the quality standards and protocols for materials and finished products, working cross functionally to ensure engineering and manufacturing are compliant.
- Conduct quality assurance tests, designing and specifying testing methods and procedures so statistical analysis can take place onsite.
- Investigate current validation and reliability protocols as part of process improvement projects.
- Act as SME for quality procedure design and improvement, developing and showing good understanding of product construction and features.
- Work with supervisor in terms of establishing gaps in the Project Validation Master Plans, creating schedules/timelines to address same and regularly reviewing the Master Validation Plan for adequacy.
- As part of a team co-ordinate the completion of Risk Management to include the use of tools such as Failure Modes Effect Analysis (FMEA), Fault Tree Analysis etc. to all product groups.
- Level 8 degree in quality engineering or similar engineering and science with four years or more in a medical device manufacturing.
- Knowledgeable in Quality Systems, validation standards, policies, procedures and methodologies. Knowledge, understanding and implementation of GAMP5 is an advantage.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
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