Senior Quality Engineer – Design Assurance
Our client is a global medical technology company based in Limerick is seeking 2x Senior Quality Engineers – Deign Assurance.
The design assurance Quality Engineer is involved in the new product development and product maintenance through the application of Quality engineering skills. Plays an active role in the processes to ensure products meet quality standards consistent with both Corporate and division policies, while meeting design controls, risk management, change control requirements and other applicable regulatory requirements.
As senior Quality Engineer you will:
- Be Design Assurance Quality Engineer on project core teams (PM, R&D, RA, Clinical Marketing systems Engineering for the design change projects and develop close relations ship with other quality functions (plant quality engineering, Supplier quality assurance)
- Be responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction
- Write project quality plans
- Lead risk management activities within the project
- Assist / conduct Failure investigations and problem-solving sessions
- Ensure process validation activities are completed appropriately and make the link with product design wherever needed
The successful candidate will have:
- Minimum level 8 degree in related discipline and have proven expertise in design assurance including design controls and risk management (ISO 14971), reviewing and approving test protocols, SPC, experience working with Design History Files
- Experience working in the Med device sector
- Additional experience with Software Quality, Capital equipment validation and reliability testing is an advantage
If you would like to discuss this role, please reach out to Louise Whitty on 021 2359140 / email@example.com
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