Our client, a leader in medical science for more than 40 years, are committed to solving the challenges that matter most – united by a deep caring for human life. Their mission is to advance science for life, transforming lives through innovative medical solutions that improve patient lives, create value for their customers, and support employees and the communities in which they operate.
We are seeking to speak to Design Quality Assurance Engineers Level II (Cutting Balloon PDP) who are seeking a role on a permanent basis to join our clients expanding team.
Job Purpose:
As part of the Design Quality Assurance team, you will play a key role in demonstrating commitment to the Quality Policy (patient safety and product quality) by executing sound quality practices and maintaining an effective quality system. In addition, you will support the application of Design Controls in projects, initially supporting a Product Development Process (PDP) project.
The Design Quality Assurance team supports a wide product portfolio including drug eluting therapies (drug-coated stents and drug-coated balloons), balloon dilatation catheters and cutting balloons for Interventional Cardiology. The successful candidate may flex across projects to support quality, compliance, material continuity, and design Value Improvement Projects (VIPs), ensuring that all design changes are compliant to associated regulations and procedures.
Key Responsibilities:
- Effective understanding of requirements and procedures that govern medical device Design Control.
- Understanding of Design Assurance requirements to ensure project deliverables comply with all internal and regulatory requirements.
- Develop and maintain the PDP Design History File, supporting deliverables including design inputs, design outputs, design verification, design validation, useability risk management and design reviews.
- Provide design quality support in the resolution of PIRs, CAPAs, NCEPs, and regulatory requirement changes.
- Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations team environments to provide technical and quality systems input.
- Draws conclusions and makes appropriate decisions from test data using excellent analytical and problem-solving abilities.
- Ownership of design change projects including scoping, assessment and implementation.
- Drive updates to documents within the Risk Management File, such as the Hazard Analysis, Task and Use Error Analysis and Design FMEA.
- Ensure and maintain regulatory compliance with appropriate guidance documents such as company SOP/WI’s and EU/FDA/Global guidelines.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Education & Experience:
- NFQ Level 8 qualification in a STEM discipline
- Min 3 years experience industry experience; Design Assurance experience would be an advantage
- Experience in areas such as new product development, design control, risk management, design change, and standards compliance (to regulatory requirements) would be an advantage
- Strong technical capabilities, communication and collaboration skills, and ability to adapt and flex across projects
- Proven ability to work well both as part of a team and individually.
- Is enthusiastic and fully motivated to develop their career, to demonstrate best practices in line with the department and site objectives and continually seeks to drive improvements in product and process quality.
For more information on this role please contact Christopher O Toole for a confidential discussion.