documentation Lead Corrective actions deliverables to ensure implementation are robust enough to prevent reoccurrence of issues Assist with gathering evidence for internalaudit requests as needed as well as being able to conduct IA walkthroughs of key controls Close collaboration with the Global Business Execution team and More ❯
Currently, ophthalmic biologic drugs represent a $14B market worldwide with growth projections reaching more than $22B by 2024. Our dual strategy includes the internal development of sustained-release therapeutics alongside the development of external strategic collaborations with major pharmaceutical partners. To date, Re-Vana has achieved significant progress … key member of the Belfast-based team. Reporting to the COO, he/she will work extensively with the CEO, CTO, and the internal scientific team. This is an outstanding opportunity to help build and contribute significantly to the strategic success of a well-capitalized, highly innovative startup … federal, state, and international regulations and guidance documents, as applicable (QSR, cGMP, ISO, ICH, etc.). Support NCMR, CAPA, Complaint, and InternalAudit investigations as needed. Thoroughly document all issues related to quality control, QSR, cGMP, ICH, and ISO compliance. Support company goals and objectives, policies, and More ❯
including testing and CI/CD deployment Collaborate cross-functionally to deliver innovative, high-quality solutions Drive continuous improvement and system optimisation through internal audits What We're Looking For: 3-5 years’ experience in a Salesforce development role Strong experience with Lightning, Apex, and Salesforce APIs Excellent More ❯
and maintain policies and documentation to ensure compliance with ISO standards. Coordinate with various departments to ensure seamless integration of ISO requirements. Conduct internal audits to assess compliance and identify areas for improvement. Provide training and support to staff on ISO standards and procedures. Ensure third party suppliers More ❯
and Hardware) and Customer Support teams to investigate and identify root causes of quality issues from customer complaints, internal non-conformances, and audit findings. Assist with implementing CAPAs and closing non-conformances. Work with cross-functional teams on documentation, risk management, and validation activities. Support quality compliance … for SaMD products, including lifecycle and version control. Participate in internal and external audits. Analyze quality data and contribute to process improvements. Required Experience: At least 2 years of experience in a Quality role within the medical device industry. Hands-on knowledge of ISO 13485 and 21 CFR … to work independently and prioritize tasks. Excellent communication, interpersonal, organizational, and IT skills. Helpful Experience: Experience with electronic Quality Management Systems (eQMS). Internal auditor qualification. Exposure to software as a medical device/IEC 62304. Technical or procedural writing experience. Familiarity with medical device regulatory requirements in More ❯
