QA/ra Project Specialist - North Wicklow
QA/RA Project Specialist - North Wicklow. Purpose of job: 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. Essential responsibilities: • Support new project 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. • 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 requirements: • An advanced life science degree with experience in medical devices or biological sciences. • At least 2 to 5 years' experience of which at least 1-2 years’ industrial 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.
128 days ago