Job ID 550
Experience 5 Years
Industry Medical Device
To ensure that the company’s QMS and quality practices remain compliant with appropriate standards and regulations including ISO13485:2016 and 21 CFR Part 820.
Good, all–round knowledge of medical device quality systems with direct experience of EN ISO 13485:2016, 21 CFR Part 820, EU MDR and UK MDR, ideally with experience of transitioning from
EU MDD to MDR.
A minimum of 5 years’ experience in QA or RA in a highly regulated manufacturing environment, with at least 2 years in medical devices or diagnostics.
Extensive experience handling deviations and non conformances, investigations, root cause analysis and corrective/preventive action plans.
Experienced in auditing to EN ISO 13485:2016.
A graduate qualification or equivalent, preferably in scientific or technical discipline