CY Partners
Salary: c. £35,000 – £45,000
Location: County Durham
Contract: Permanent
Start Date: Immediate
Are you looking for opportunities focused on the validation of medical devices? An exciting new opportunity is live with a medical device manufacturer based in County Durham looking to expand their validation/quality team.
As a Validation Engineer, you will be responsible for ensuring that validation plans and reports for products, processes and software are created and maintained. As well as product or process validation of products from product development through to market launch, focused on the medical device/IVD industry.
Your responsibilities will include:
- Leading validation tasks associated with the processes and software related to product design, conducting validation protocols, reports, URS, and other appropriate documentation.
- Create plans for necessary revalidation activities based on conducted risk assessments for all equipment, processes, and software.
- Create changes and validation strategies for products and processes. Ensuring training and documentation for changes.
- Assist in the management of QMS documentation requests related to risk management, validation, and projects/products.
- Create risk analysis for new projects related to product development and processes.
- Perform all activities in compliance with ISO 13485 and 21 CFR 820.
- Handle changes in line with company SOPs, and work with wider teams to complete work and documentation compliant to necessary standards and regulations.
About you:
- You will hold a relevant Scientific degree.
- Practical knowledge/experience of ISO 13485 and 21 CFR 820 related to validation. As well as medical device or IVDR regulations.
- Ability to work to tight deadlines and meet targets.
- Excellent organisational abilities and problem-solving skills.
- Experience in validation and change control for medical device or IVD industry. As well as risk management, CAPA and NCR management.
- Experienced in document control, QMS activities and ISO 13485 auditing.
If this opportunity interests you, email your CV to: .
To apply for this job please visit uk.whatjobs.com.