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Job Description
Seeking a QA (Validation) Engineer for a 6-month contract to manage product introductions and change controls in accordance with ISO 13485 and MDR 2017/745.
Our client, a leading medical device company, requires a highly skilled individual to oversee the validation process, ensure compliance with regulatory requirements, and contribute to the company's growth and success.
Key Responsibilities:
- Ensure effective management of product introductions and change controls in accordance with ISO 13485 and MDR 2017/745
- Participate in new product introductions programs to ensure compliance with regulatory requirements
- Generate Product Technical Files and associated studies in accordance with MDR 2017/745
- Complete validation programs, including risk analysis, VMP, IQ's, OQ's, and PQ's
- Manage QA/Technical/Associate Engineers as applicable
- Review and release batch paperwork for product release
- Adhere to plant safety requirements and health and safety regulations
Requirements:
- Degree in Engineering/Manufacturing/Quality with emphasis on Medical Devices/Biomedical
- 2-3 years of previous experience as Quality/Validation Engineer in Medical Device/Pharma Environment
- Minitab experience is highly desirable
About the Company:
Our client is a leading medical device company based in Leitrim, committed to delivering high-quality products and services.