Senior Quality Engineer – Product Development

About the role

We are seeking a Senior Quality Engineer to lead quality engineering activities throughout the product development lifecycle for medical devices. The role partners with engineering, product management, clinical, regulatory, and project teams to ensure design controls, risk management, and quality system requirements are met and documentation is inspection‑ready.

Key responsibilities

• Partner with cross‑functional teams to support new product development and design changes.
• Provide quality leadership across the product development lifecycle, planning and executing design controls and risk management activities.
• Lead design assurance tasks such as design planning, reviews, verification, validation, design transfer, and change management.
• Review design documentation to ensure completeness, traceability, and regulatory compliance.
• Maintain Design History Files, technical documentation, and associated records in an inspection‑ready state.
• Oversee engineering change activities, assessing impact on performance, risk, and regulatory submissions.
• Support broader QMS activities including CAPA, non‑conformance investigations, supplier quality, and audits.
• Coach teams on design controls, risk management, and quality system requirements.

Required profile

• Extensive experience in medical device quality engineering or a related field.
• Proven ability to work independently and influence cross‑functional teams in a fast‑paced environment.
• Strong understanding of design controls, risk management, and regulatory requirements (e.g., FDA, ISO 13485).
• Excellent documentation and communication skills.

Required skills

• Design Controls
• Risk Management
• Design History Files (DHF) management
• CAPA processes
• Non‑conformance investigations
• Supplier quality management
• Internal and external audit participation
• Regulatory submission support