Job Description

Design Quality Engineer - North Dublin

Ref No: AM17545

County Dublin, Republic of Ireland

Competitive salary

Design Quality Engineer - North Dublin.

In this role you will:

• Serve as Subject Matter Expert (SME) for the application of Design Controls, while supporting development and design change teams in accordance with regulatory expectations and company procedures
• Support deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products and related system software throughout the product lifecycle.
• Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations related to Design Controls, Risk Management, Quality Engineering (e.g., Quality System Regulation, EU IVDD / IVDR, ISO standards, etc.)
• Ensure the comprehensive completion of risk management, Design Verification, Process Validation, and Design Validation activities for products and processes
• Support the development and validation of appropriate test methods for product and process performance
• Ensure active and thorough investigation of quality issues and effective corrective and/or preventive action
• As the SME, be capable of providing competent Supplier Quality audit support with respect to the implementation of all Design Controls elements
• This is an individual contributor role. The DQ Professional provides specialised direction to professional counterparts on teams.
• This position is responsible to provide direction in the areas of Design Controls & Risk Management to cross-functional teams responsible for new product development, and Design Changes to commercial products. As a Subject Matter Expert (SME), the individual must be able to participate in Quality Management System improvement projects and training efforts related to any of the elements within Design Controls.

Interested applicants should have:

• Bachelor’s degree in Engineering or related Science discipline (QQI level 8).
Circa 3 or more years' relevant experience supporting the development and/or sustaining engineering associated with Medical Devices in a regulated environment, with a core appreciation of global Medical Device regulations and specifically the implementation and application of design controls.
• Leadership skills and ability to influence cross-functional teams to drive work scope to compliant and successful completion.
• A self-starter, with a bias for action with the ability to support projects through to completion. Good organizational skills.
• Cross-technology and cross-discipline collaboration skills


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