Director of Quality Assurance

About the role

CoMind is developing non‑invasive neuromonitoring technology for clinical brain monitoring. As Director of Quality Assurance you will lead the quality function across the quality management system, design quality, and supplier quality, working closely with engineering and regulatory affairs.

Key responsibilities

• Lead and develop the Quality team, fostering a high‑performance culture.
• Ensure the QMS complies with FDA 21 CFR Part 820, ISO 13485 and 21 CFR Part 11.
• Own the annual ISO 13485 certification audit, FDA inspection readiness and internal, supplier and customer audit programmes.
• Oversee design controls, risk management (ISO 14971), usability (IEC 62366) and software development processes (IEC 62304, SaMD).
• Provide cybersecurity oversight in line with FDA pre‑market guidance.
• Lead supplier qualification, audits and manufacturing quality as the product moves to commercial production.
• Build the post‑market quality system, including complaint handling, product analytics and vigilance reporting.

Required profile

• Extensive leadership experience in Quality Assurance within an ISO 13485 environment covering design, manufacturing and customer‑facing operations.
• Proven ability to build and manage high‑performing quality teams.
• Track record of leading audits and certification programmes (ISO 13485, FDA).
• Background in medical devices, preferably complex or integrated products.

Required skills

• ISO 13485 and FDA 21 CFR Part 820 compliance.
• Design controls, ISO 14971 risk management, IEC 62366 usability.
• IEC 62304 software development processes and SaMD classification.
• Cybersecurity guidance for medical devices.
• Supplier qualification and audit management.
• CAPA, validation and post‑market surveillance processes.

What we offer

• Company equity plan for all employees.
• Salary‑sacrifice pension scheme.
• Private medical, dental and vision insurance.
• Unlimited mental‑health support and 1:1 professional sessions.
• Unlimited holiday plus bank holidays and one remote week per quarter.
• Daily lunch voucher and free dinner on late‑work days.
• Twice‑weekly fresh fruit deliveries and a wide snack selection.
• YuLife subscription converting steps and meditation into store discounts.