Back to Job SearchROLE OVERVIEW
We are currently looking for a Quality Engineer, Compliance to join a leading biotherapeutics pharmaceutical research and development organisation within their Devices Centre of Excellence. Based in our client’s innovative facility, this is an exciting opportunity for a dedicated professional to contribute to cutting-edge combination product development programmes throughout their lifecycle.
In this role, you will provide expert guidance on design control and risk management, ensuring compliance with industry standards and supporting both clinical and commercial applications. This position offers the chance to work with multi-disciplinary teams and external partners, shaping product safety and quality standards in a dynamic environment.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Quality Engineer, Compliance will be varied however the key duties and responsibilities are as follows:
• Lead design control and risk management activities for combination product development programmes, ensuring deliverables are properly authored, approved, and maintained to support clinical trials and commercial licences.
• Support and facilitate effective risk management activities with external design companies and manufacturing facilities related to assigned projects.
• Ensure all combination product development activities are compliant with relevant quality and regulatory standards, both internal and external.
• Provide input and support to design validation activities, including human factors engineering assessments.
• Assist in the assessment of external design companies and suppliers regarding their quality systems, facilities, and procedures to support device development and supply.
• Support investigations into device design and manufacturing issues arising from clinical trials and commercial production.
• Contribute to the generation of regulatory submission data and content for assigned device projects.
• Support internal and external audits of the Quality Management System within the Centre of Excellence.
• As the Quality Engineer, Compliance you will ensure all activities uphold compliance and support continuous quality improvements.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Quality Engineer, Compliance we are looking to identify the following on your profile and past history:
• A Degree or higher level in a relevant science or engineering discipline (e.g., biomedical sciences, mechanical engineering, materials sciences, chemical engineering) with proven experience in combination products or medical device industries.
• Extensive knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation, with practical experience working in accordance with these standards.
• Proven experience in design controls, risk management, and human factors engineering related to medical devices or combination products.
• Familiarity with device manufacturing processes and an understanding of GMP requirements.
WHAT’S IN IT FOR YOU?
Joining our client provides an opportunity to be part of a pioneering organisation committed to innovation and quality in medical device development. You will be integral to projects that have a real impact on patient safety and regulatory success, with a collaborative and supportive team environment.
This role offers competitive pay, with a maximum bill rate dependent on experience, and the flexibility of two and a half days onsite per week, supporting work-life balance in a vibrant, forward-thinking workplace.
Key Words: quality assurance / compliance / medical devices / regulatory standards / design control / risk management / combination products / GMP / ISO standards / human factors / product lifecycle / audit / internal/external collaborations
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career."
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
