Senior Quality Assurance Engineer

GxPeople Global; United Kingdom; Remote; GBP 60,000 - 80,000; Full time

Job summary

A leading Medtech Start-up in the UK is seeking an experienced Senior Quality Systems Engineer to take ownership of the Quality Management System (QMS). This remote-based role involves ensuring compliance with global regulatory requirements, leading audits, and managing supplier oversight. The ideal candidate has 8+ years of experience in the medical device sector and a strong background in QMS implementation. Join us to play a pivotal role in ensuring patient safety and successful market access.

Benefits

Competitive package

Opportunity to shape quality strategy

Remote work with travel for audits and inspections

Qualifications

• 8+ years' Quality/Compliance experience in the medical device or pharmaceutical sector.
• Strong leadership in QMS implementation (ISO 13485, ISO 14971, GMP).
• Proven background with design controls, risk management, supplier audits, and regulatory inspections.

Responsibilities

• Develop, implement, and maintain ISO 13485-compliant QMS.
• Lead audits, risk management, CAPA, and management reviews.
• Ensure compliance with GMP, GDP, MA requirements, and regulatory inspections.

Skills

Quality Management Systems

Risk Management

Regulatory Compliance

Leadership

Design Controls

Education

Degree in Pharmacy, Biomedical Engineering, Quality, or related discipline

Job description

Overview

Senior Quality Systems Engineer - Medical Devices / Combination Products. On behalf of a well funded Medtech Start-up we're seeking an experienced Senior Quality Systems Engineer to take ownership of the Quality Management System (QMS) and ensure full compliance with global regulatory requirements. This is an end-to-end role covering design controls, manufacturing, supplier oversight, quality and compliance, and post-market surveillance.

Key Responsibilities

• Develop, implement, and maintain ISO 13485-compliant QMS.
• Lead audits, risk management, CAPA, and management reviews.
• Oversee suppliers, CMOs/CDMOs, testing labs, and QP release activities.
• Ensure compliance with GMP, GDP, MA requirements, and regulatory inspections.
• Manage regulatory submissions, technical agreements, and product quality reviews.
• Drive continuous improvement initiatives and lead risk assessments (ISO 14971, ICH Q9).

About You

• Degree in Pharmacy, Biomedical Engineering, Quality, or related discipline (Master's preferred).
• 8+ years\' Quality/Compliance experience in the medical device or pharmaceutical sector.
• Strong leadership in QMS implementation (ISO 13485, ISO 14971, GMP).
• Proven background with design controls, risk management, supplier audits, and regulatory inspections (MHRA/Notified Bodies).
• Experience with combination drug/device products highly desirable.
• Eligible for or working toward QP status a plus.

The Offer

• Remote-based role with travel for audits, inspections, and supplier oversight.
• Competitive package and opportunity to shape quality strategy at a senior level.
• Apply today to play a pivotal role in ensuring patient safety, product compliance, and successful market access.