Quality Assurance Engineer
This Quality Assurance Engineer will work with a growing medical device company who have recently massively updated their operations with the aim of strong growth. This person will oversee establishing, implementing and maintaining the Quality System and procedures on site.
- Conduct Trend and Data analysis to enable continuous improvement onsite and lead the implementation of data driven quality assurance
- Utilise knowledge of FDA, European, Canadian, Japanese and other international regulations to implement broad compliance throughout the site
- Conduct CAPAs, NCRs and Risk analysis
- Undertake required validation of manufacturing lines and equipment in accordance with regulatory standards
- Create and maintain quality documentation
- Conduct audits, including closing out audit findings and creating and determining proper corrective and preventative action
- Level 8 degree with 3 years or more experience within medical device or similarly highly regulated industry
- Must understand FDA, European, Canadian, Japanese or other International Regulatory requirements
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: email@example.com
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