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 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.
Process & Manufacturing Support 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.
Quality Systems & Compliance 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.
Problem Solving & Continuous Improvement 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.
Training & Support Provide training and guidance to personnel on quality procedures, design controls, and regulatory requirements as required.
Experience Requirements 58 years of experience in the medical device industry.
Demonstrated experience with: Design Controls New Product Introduction (NPI/NPC) Statistical analysis Process validation Education & Qualifications Bachelors 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.