Summary:
Quality Engineer required for a large Medical Device client based in Dublin. Must have experience in a high volume regulated manufacturing environment. Experience with Quality Systems and processes is desirable.
Responsibilities:
Drafting and execution of all protocols including SAT, FAT, IQ, OQ and PQ and completion of reports for approval by site management & customer review.
Deviation management.
Enthusiastic, strong organisational skills.
Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
Qualifications & Experience:
Proficient in Quality systems and processes: NCEs, CAPAs, SCARs, Audit Processes.
Good attention to detail.