Ref No: AM17075
Co. Dublin, Ireland
Design Quality Professional - North Dublin
Our client seeks a Design Quality Professional to work in an ISO 13485 and FDA 21 CFR Part 820 IVD product development and manufacturing environment.
You should have experience in product and process quality including support of new product development, sustaining engineering (Design Change) and design transfer, specifically to support a new product’s introduction at this site.
This is an excellent opportunity to work in a leading manufacturing facility. 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.
The Dublin site is currently involved in two new product introductions, so this is an exciting time to join a team of Quality professionals at the Dublin manufacturing site.
• 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.
• Utilise quality engineering principles and problem-solving skills (risk analysis, problem solving methodologies, statistical techniques, etc.) to develop and optimise 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 utilises 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.
Qualifications/Skills/Experience for this role:
This position is responsible for providing direction in the areas of Design Controls & Risk Management to cross-functional teams responsible for new product development, and Design Changes to commercial IVD hardware products. As a Subject Matter Expert (SME), the individual must be able to lead Quality Management System improvement projects and training efforts related to any of the elements within Design Controls.
At a minimum, a BA/BS degree (in a Life Science, Engineering, or Physical Science preferred).
Knowledge and Experience:
• 8 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 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 and the ability to support projects through to completion. Good organisation skills.
• Cross-technology and cross-discipline collaboration skills
• Understanding of Electromechanical Engineering, Software Development, Immunology and Haematology diagnostic system technologies is an advantage.
This is an individual contributor role. The DQ Professional provides specialised direction to professional counterparts on teams.