Senior Design Control & Quality Engineer

Senior Design Control & Quality Engineer Consultant

with strong technical expertise and a hands‑on, pragmatic mindset to support the development and lifecycle management of innovative medical devices. The ideal candidate will work closely with cross‑functional teams, driving quality initiatives and ensuring alignment with regulatory and compliance requirements throughout product development.

This role combines deep knowledge of Design Control and Quality Engineering with the ability to operate effectively in a fast‑paced, highly regulated environment. The successful candidate will contribute to product development, performance evaluation, and process optimization, playing a key role in maintaining high quality standards and supporting complex programs.

• Lead and support Design Control activities throughout the product development lifecyc
• Ensure compliance with applicable quality system requirements and medical device regulations.
• Drive product performance evaluation and verification activities.
• Support process performance monitoring, continuous improvement, and risk mitigation initiatives.
• Participate in design reviews and cross‑functional project meetings.
• Collaborate with R&D, Manufacturing, Quality, Regulatory Affairs, and Operations teams.
• Contribute to technical documentation, change control, CAPA, and quality investigations.
• Support validation and verification activities as required.
• Ensure traceability and compliance throughout development and manufacturing processes.

• Minimum 7-8 years of experience in Quality Engineering, Design Assurance, or Design Control within a regulated industry.
• Ideally 10-15 years of relevant industry experience.
• Strong expertise in Design Control methodologies and product development processes.
• Proven experience in Product Performance evaluation and analysis.
• Strong background in Process Performance, process improvement, and quality systems.
• Experience working in medical devices, life sciences, or other highly regulated industries.
• Excellent communication and stakeholder management skills.
• Fluent English is mandatory.

• Experience working within international and multidisciplinary environments.
• Familiarity with risk management, verification & validation, CAPA, and change management processes.
• Ability to operate autonomously while collaborating effectively within project teams.

7+ years of experience

Primarily on‑site presence is preferred to support close collaboration with engineering and quality teams. A hybrid working arrangement can be considered, with up to 1‑2 days per week of remote work depending on project requirements.