Ref No: AM17929
County Wicklow, Republic of Ireland
QARA Project Engineer - North Wicklow.
The overall purpose of this job is to provide QARA support for all on-going and new projects. Specifically projects related to assay development and instrument projects, including software, but also to include change management projects and improvements to ensure projects are delivered on time and conform to applicable Quality and Regulatory requirements. Responsibility for Risk Management and Usability Engineering for new product introductions, and on-going maintenance of these files throughout the entire product lifecycle.
Support new projects introductions to the site by providing Quality, Risk and Usability expertise.
Review and approval of Design Verification and Design Validation documentation.
Initiate Risk Management and Usability activities for new projects.
Ongoing maintenance of Risk Management Files and Usability Engineering Files.
Work constructively with team members from R&D, Marketing, Operations, Quality Assurance, Technical Support, Clinical Affairs, Customer Service, and Finance, and the wider group.
Assist in ensuring that product Technical Files and Design History Files comply with requirements and are kept up to date.
Support the product registration and regulatory submissions processes where required.
Qualifications and experience sought:
An advanced life science degree with experience in medical devices or biological sciences
At least 2-5 years' experience of which at least 1-2 years' experience in a QARA role in the Medical Device or similar industry
Knowledge of FDA QSR, 21CFR820, ISO 13485, HC Medical Device regulations, ISO 14971, IVD Regulation 2017/746/EU
Quality Auditor qualification desirable
Demonstrated competence in biochemical techniques and statistical concepts.