Be part of an established medical device company with an exciting future who have grown from a start-up in the vascular sector. You will be part of plenty exciting of NPD and NPI projects.
- Provide leadership and expertise for FDA Quality Systems regulations and ISO13485 while also being highly knowledgeable in regulatory compliance and requirements.
- Perform variability studies and support validation and testing procedures through collaboration with Operations and R&D.
- Lead NCR and CAPA activities while also being one of the key points of contact for the requirements for first article inspection, incoming, in process inspections, and lot release testing, including sampling strategies and test methods.
- Provide technical QA support to assigned inspection and manufacturing area.
- Participate in process evaluations, develop and execute manufacturing process valuations, determine appropriate sampling plans for subsequent routine production and participate in the training of junior quality engineers.
- Level 8 degree in science and engineering with 4 years or more experience in a medical device manufacturing environment.
- Prior experience in ISO 13485 and/or QSR 820 FDA regulated environment is required.
- Knowledgeable with industry standards, QSR FDA820, ISO 13485 medical device requirements and IS0 14971 are required.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: email@example.com
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