Job Title: Senior Quality Engineer – Design Assurance & Compliance
Location:
Department: Quality Assurance / Quality Engineering
Reports To: Director of Quality
Job Summary
We are seeking a highly skilled and detail-oriented Senior Quality Engineer – Design Assurance & Compliance to support and drive quality activities across the product development lifecycle. This role will focus on design control, verification & validation (V&V), software and product quality, and regulatory compliance. The candidate will play a key role in ensuring that all project and product deliverables meet global standards such as ISO 13485, EU MDR, and IEC 62304, while also supporting Technical File preparation for regulatory submissions.
Key Responsibilities
Process & SOP Management
- Partner with Software Engineering and Data Science teams to develop, implement, and maintain SOPs and quality processes supporting compliant product and software development.
- Ensure SOPs are aligned with ISO 13485, IEC 62304, and internal quality management system requirements.
- Drive adherence to documented procedures and support continuous process improvement initiatives across cross-functional teams.
Design Assurance & Development
- Support and ensure compliance with design control processes throughout the product lifecycle.
- Participate in design and development activities, ensuring adherence to quality and regulatory standards.
- Review and approve design documentation including design inputs, outputs, and design history files (DHF).
Design Changes & Change Control
- Manage and support design change processes.
- Assess impact of changes on product quality, safety, and regulatory compliance.
- Ensure proper documentation, traceability, and approvals for all design modifications.
Verification & Validation (V&V)
- Plan, review, and support verification and validation activities for products and software.
- Ensure V&V activities are adequately documented and meet regulatory and quality requirements.
- Collaborate with cross-functional teams to ensure test strategies align with intended use and risk profiles.
Product & Software Quality
- Oversee handling and resolution of product and software defects.
- Conduct root cause analysis and drive corrective and preventive actions (CAPA).
- Ensure alignment with software lifecycle processes as per IEC 62304.
Regulatory Compliance
- Ensure compliance with:
- ISO 13485 (Quality Management Systems)
- EU MDR (Medical Device Regulation)
- IEC 62304 (Medical Device Software Lifecycle)
- Provide quality input during audits and regulatory inspections.
Technical Documentation & Submissions
- Support preparation and maintenance of Technical Files for EU MDR submissions.
- Collaborate with Regulatory Affairs to ensure completeness and accuracy of submission documents.
- Maintain documentation in line with regulatory expectations and audit readiness.
Qualifications & Experience
- Bachelor’s or Master’s degree in Engineering, Biomedical, or a related field.
- 5–8 years of experience in Quality Engineering/Design Assurance, preferably in medical devices or regulated industries.
- Strong understanding of design control processes and product lifecycle management.
- Hands-on experience with V&V, change management, and defect management.
- In-depth knowledge of ISO 13485, EU MDR, and IEC 62304 standards.
Skills & Competencies
- Strong analytical and problem-solving skills.
- Proven experience collaborating with Software and/or Data Science teams to establish, standardize, and maintain SOPs, quality documentation, and compliant development processes aligned with regulatory and quality standards.
- Excellent documentation and technical writing capabilities.
- Ability to work cross-functionally with engineering, regulatory, and product teams.
- High attention to detail and strong compliance mindset.
- Effective communication and stakeholder management skills.
Preferred Qualifications
- Experience in medical device or SaMD (Software as a Medical Device) environments.
- Exposure to EU MDR Technical File or CE marking submissions.
- Certification in quality (e.g., CQE) is a plus.