Quality Systems Engineer

ROLE OVERVIEW

An exciting opportunity for a Quality/System Engineer to join a leading organisation in the medical device industry. Based in the area served by our client, this role offers a vital chance to contribute to the development and compliance of innovative electromechanical medical devices containing software. As a Quality/System Engineer, you will be instrumental in ensuring that the company's products meet rigorous international standards, supporting quality assurance and regulatory compliance across the product lifecycle.

• Conduct comprehensive gap assessments of technical documentation against relevant standards, including ISO 13485:2016, 21 CFR Part 820, EU MDR 2017/745, and other applicable regulations, identifying compliance gaps and suggesting remediation.
• Lead efforts to develop and implement robust design control processes for new and existing products, ensuring compliance with international standards and regulatory guidances.
• Establish and maintain traceability throughout the design and development phases, ensuring full documentation of user needs, design inputs, and verification requirements.
• Collaborate with cross-functional teams to ensure thorough design verification and validation processes, providing compelling evidence that the product meets all necessary specifications.
• Ensure ongoing compliance and continuous improvement of quality management systems within the organisation.

• A degree or higher level in a related field (e.g., Biomedical Engineering, Quality Management, or Mechanical Engineering).
• Proven industry experience in quality or system engineering within the medical device sector, particularly with electromechanical devices that incorporate software and regulatory standards such as ISO 13485, 21 CFR Part 820, and EU MDR 2017/745.
• A working knowledge and practical experience with design controls, traceability, and relevant standards including IEC 62304.

Joining our client means becoming part of a forward‑thinking organisation dedicated to advancing medical technology. You will have the opportunity to work on impactful projects within a dynamic, collaborative environment that values innovation, compliance, and professional growth. Take your career to the next level supporting vital healthcare solutions worldwide.

Key Words:
Quality Engineer / System Engineer / Medical Device / Design Controls / Traceability / ISO 13485 / 21 CFR Part 820 / EU MDR 2017/745 / IEC 62304 / Technical Documentation / Compliance

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements.