Senior Engineer- Design/Quality

Location: Kent

Seeking a Senior Quality Engineer to support product development and change control, ensuring compliance with internal quality systems and regulatory standards (ISO 13485, ISO 14971, 21 CFR 820, etc.). This role partners with cross-functional teams to integrate quality throughout the product lifecycle and reports to the Design Quality Manager.

Key Responsibilities

• Apply quality tools (risk management, design controls, V&V, CAPA) to support product development.
• Ensure compliance with global medical device regulations and standards.
• Develop and maintain risk management files per ISO 14971.
• Perform statistical analyses and sample size calculations.
• Participate in design reviews, risk assessments, and design transfers.
• Support resolution of on-market product issues and identify trends through data analysis.
• Contribute to audit readiness and continuous improvement initiatives.
• Collaborate on product and process changes with cross-functional teams.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, Software, or related).
• 7+ years in Quality or R&D in a regulated environment.
• ASQ Certified Quality Engineer (CQE) or ability to obtain within 1 year.
• Strong knowledge of QMS, FDA, EU MDR, ISO 13485/14971.
• Experience with respiratory or anaesthesia devices a plus.

Work Environment

• Office-based, mostly sedentary.
• Occasional travel (5–10%).