Job DescriptionVitalograph is the world’s leading manufacturer of medical respiratory diagnostic devices and software, used in the diagnosis of respiratory disorders, and advanced high-reliability equipment and software systems used in respiratory end-point clinical drug trials. Headquartered in the UK, Vitalograph has operations in Ireland, Germany, and the USA. Our mission is to improve patient lives by designing and manufacturing market-leading products and services.
Why Join Us?
At Vitalograph, we offer more than just a job. As a global leader in medical respiratory diagnostics, you'll be at the forefront of groundbreaking technology used to diagnose respiratory disorders worldwide. We offer:
* Pension contribution from the company, ensuring your future is secure.
* Private health insurance for peace of mind.
* Educational assistance programme to fuel your professional growth.
* Clear career development opportunities, with room to grow and make an impact.
The Role
Reporting to the Quality Manager, the Quality Engineer is responsible for supporting and directing operations and the QMS. You will collaborate with the wider team, working to tight deadlines in a dynamic environment.
Key Responsibilities
Support and mentor operations and R&D teams in quality engineering, develop workflows for eDMS, oversee medical device vigilance and reporting, draft SOPs and QMS documentation, ensure timely record-keeping, report metrics to management, assess NC, CAPA & complaints using root cause analysis, contribute to continuous improvement initiatives, support product registration, and perform other compliance or QMS activities as assigned.
Key Measures of Success
Meeting weekly commitments, performing duties effectively and efficiently, communicating well internally, and fostering good cooperation.
Key Requirements
A third-level qualification or equivalent in science or engineering, at least 5 years’ experience in medical device manufacturing within QA, with ISO 13485, CE Marking, and FDA QSRs, plus 3 years’ experience with medical device vigilance and risk understanding. Previous QA or internal auditor experience, auditor certification (cost covered by Vitalograph), strong project planning, assertiveness, interpersonal skills, proficiency in MS Office, good English writing skills, and willingness to travel.
Key Skills
Motivated, strategic thinker, excellent organizational skills, decisive under pressure, responsible, independent, collaborative, communicative, and eager for continuous improvement. #J-18808-Ljbffr