Our Client, a Multinational based in North Dublin requires a Design Quality Engineer to join their team with experience in product and process quality including new product introduction. The client is in the process of introducing two new products and this role will interact with a number of areas of the business to achieve that goal. Successful candidates will be working in an ISO 13485 and FDA regulated environment, so experience in a similar setting would be a plus.

The quality function works cross-functionally with engineering, production and procurement to cover a wide area of responsibilities such as Change Management, Inspections/ Regulatory Audits with respect to design change, product development and design controls, Verification, Validation and Risk Management.

This is a permanent role. For more info, call Cormac Spencer on 01 845 4651.

Salary:  Neg. Depending on Experience

Benefits:  Pension, Healthcare, Gym, Heavily subsidised canteen, Parking, Annual Review, Bonus, Bike to Work Scheme.

Responsibilities:

• Serves as Subject Matter Expert (SME) for application of Design Controls, while supporting development and design change teams in accordance with regulatory expectations and company procedures
• Leads effective deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of IVD Systems and related system software throughout the product lifecycle.
• Utilize quality engineering principles and problem-solving skills (risk analysis, problem solving methodologies, statistical techniques, etc.) to develop and optimize products/processes that are aligned with the overall Quality and Business vision.
• Provides 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.)
• Ensures 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
• Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results
• As the SME, capable of providing competent Supplier Quality audit support with respect to the implementation of all Design Controls elements
• Participates as subject matter expert during regulatory inspections

Capabilities:

• 5 or more years relevant experience supporting the development and/or sustaining engineering associated with IVD hardware systems in a regulated environment with a core appreciation of FDA regulations and specifically the implementation and application of design controls.
• Strong capability to lead Quality Management System improvement projects and Training efforts related to any of the elements within Design Controls.
• Strong leadership skills with the ability to influence teams to improve productivity.
• Excellent organisational skills, with the ability to support projects through to completion.
• Good understanding of Biochemistry, Immunology, Hematology diagnostic technologies would be an advantage.
• At a minimum, a BA/BS degree (in a Life Science, Engineering, or Physical Science preferred).

If this role sounds like you, Call US Now on 01 845 4651!

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01 845 4651

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