Senior Device Development Engineer
- BBBH790040 Aug 11, 2021 Competitive
An excellent opportunity has arisen for a Senior Device Development Assurance Engineer to join a speciality pharmaceutical company based in Dublin.
This role will be a permanent position and it is a very exciting time to join the company as they have several new and existing projects ongoing.
The successful candidate will have minimum 3 years' experience working in a similar role in device delivery. You will have experience in Medical Device, Pharma with device or combination device. A solid understanding of ISO13495 and GMP is essential. Experience in design control and design assurance preferential. A degree in Biomedical, Mechanical or Science essential. This role will be remote to begin but the candidate must be flexible to be on site based on the business needs.
- Support the device development programs through design and development lifecycle for combination and medical products through quality management systems, regulations, and international standards.
- Maintenance of ISO13485:2016 QMS, internal audits, CAPAs, complaints while adhering to 21 CRF 820 and Medical Device Regulations.
- Participate in external audits including corporate, health authority and certification audits.
- Support risk management activities in line with ISO14971:2019.
- Assess compliance with design control requirements into the global device development product portfolio.
- Supporting technical transfers of products and processes into commercial manufacturing facility.
- Collaborate with affiliate sites, collaborators, 3rd party to ensure objectives are established.
- Support Health Authority submissions as needed.
If this role is of interest to you, please click 'Apply Now' or for more information contact Aoife on email@example.com or 021 2300 200.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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