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Senior Design Assurance Engineer
Industry specialist
Tommy McKeown
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Permanent
Senior Design Assurance Quality Engineer
Role Summary
The purpose of this role is to provide Design Control and Quality Engineering support for medical device products within a manufacturing environment. The position supports product development, regulatory compliance, and manufacturing quality, contributing to the successful commercialization of products and overall business growth.
Key Responsibilities
Design Assurance & New Product Development
Role Summary
The purpose of this role is to provide Design Control and Quality Engineering support for medical device products within a manufacturing environment. The position supports product development, regulatory compliance, and manufacturing quality, contributing to the successful commercialization of products and overall business growth.
Key Responsibilities
Design Assurance & New Product Development
- Act as the Quality representative and core team member on New Product Commercialization (NPC) projects.
- Lead and support Design Control activities, ensuring compliance with applicable regulatory and quality standards.
- Facilitate risk management activities, including Risk Assessments and Design Failure Mode and Effects Analysis (DFMEA).
- Support the development and review of product specifications, engineering drawings, and technical documentation.
- Contribute to Process Failure Mode and Effects Analysis (PFMEA) and process validation activities for new product introduction projects.
- Provide quality guidance and oversight during product and process development.
- Perform internal audits in accordance with the annual audit schedule to ensure compliance with ISO 13485 and FDA Quality System Regulations (QSR).
- Ensure design and development activities meet all applicable regulatory and quality requirements.
- Support Corrective and Preventive Action (CAPA) investigations and implement effective solutions related to new product projects and manufacturing processes.
- Perform statistical analysis to support validation activities and continuous improvement initiatives.
- Provide training and guidance to personnel on quality procedures, design controls, and regulatory requirements as required.
- 5–8 years of experience in the medical device industry.
- Demonstrated experience with:
- Design Controls
- New Product Introduction (NPI/NPC)
- Statistical analysis
- Process validation
- Bachelor’s degree in Engineering or a related Science discipline.
- Professional quality qualification preferred, such as Certified Quality Engineer (CQE).
- Experience working in regulated environments aligned with ISO 13485 and FDA requirements.
