Job Title:
Senior Quality Engineer

Reporting To:
Quality Manager

Role Overview

The Senior Quality Engineer will play a key role in driving compliance, supporting new product introductions (NPI), and maintaining the effectiveness of the Quality Management System (QMS). This position requires strong technical knowledge, leadership ability, and hands-on experience within the medical device sector.

Key Responsibilities

• Drive compliance and ensure achievement of organisational quality objectives.

• Support the implementation and continuous improvement of NPI processes and systems to enhance quality, efficiency, and product safety.

• Implement and maintain Lean Product Development practices.

• Develop and execute test strategies, methods, and validation protocols (including sterilisation, packaging, biocompatibility, and process validations).

• Support the Quality Management System, including management reviews, design control, change control, CAPA, risk management, and document control.

• Ensure the QMS remains compliant with ISO and FDA standards and other applicable regulations.

• Collaborate closely with project management teams and customers to successfully deliver projects that meet or exceed expectations.

• Mentor, develop, and support engineers and technicians, providing guidance, coordination, and feedback as needed.

• Support internal, supplier, customer, and regulatory audits, as well as certification activities.

Requirements

• Degree in a science, engineering, or technical discipline.

• Minimum of 5+ years’ experience within the medical device industry.

• Proven experience establishing and maintaining all aspects of a Quality Management System.

• Experience with cleanroom management, validation processes, and sterilisation validation is advantageous.

• Demonstrated ability to build, lead, and motivate cross-functional teams.

• Strong communication and stakeholder management skills, including experience engaging with senior leadership and customers.

• Experience in project environments and manufacturing product release processes is highly desirable.

• Agile, innovative, and proactive with strong problem-solving abilities.

• Experience with CAPA, risk management, document control systems, and NPI processes preferred.