Posted: 16 June
The role
Senior Design Assurance Quality Engineer
Medical Device Sector | Mayo
Summary
The purpose of this role is to provide Design Assurance and Quality Engineering support for medical device product development and manufacturing activities, ensuring compliance with applicable regulatory requirements and quality standards while contributing to business growth and operational excellence
Key Responsibilities
Act as the Quality representative and core team member on New Product Development (NPD/NPI) projects.
Facilitate Design Control activities, Risk Management processes, and Design Failure Mode and Effects Analysis (DFMEA).
Support product specifications, technical drawing development, Process Failure Mode and Effects Analysis (PFMEA), and Process Validation activities for new product introductions
Conduct internal audits in accordance with ISO 13485, FDA regulations, and Quality System Requirements (QSR).
Support CAPA investigations, root cause analysis, and problem-solving initiatives related to products and manufacturing processes
Perform statistical analysis to support quality improvement and process capability assessment
Develop and deliver quality-related training to personnel as required
Ensure compliance with quality management system requirements and regulatory standards throughout the product lifecycle
Experience Required
5–8 years’ experience within the Medical Device industry
Proven experience supporting Design Control and New Product Introduction (NPI) projects
Experience in statistical analysis, process validation, and risk management activities.
Strong knowledge of quality systems, regulatory requirements, and continuous improvement methodologies
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