Overview
We are looking for a Design Quality Engineer to join a leading diagnostics manufacturer on a long-term contract running until at least the end of 2027. This role requires hybrid on-site presence in Newcastle and focuses on leading design assurance and quality control activities across the product lifecycle while ensuring regulatory compliance and effective risk management.
Responsibilities
- Lead design assurance and quality control activities throughout the product lifecycle.
- Serve as the subject matter expert for design control and risk management.
- Provide quality assurance leadership for product development and regulatory submissions.
- Develop, review, and approve key design control deliverables.
- Oversee design quality control for new product introductions.
- Support pre-market approvals and regulatory submissions with necessary documentation.
- Collaborate with cross-functional teams to facilitate inspections and audits.
- Drive continuous improvement in quality management systems (QMS).
Requirements
- Extensive experience in IVD medical device development and design controls.
- Strong knowledge of regulated product development practices.
- Expert understanding of international quality and regulatory standards such as 21 CFR 820 and ISO 13485.
- Demonstrated ability to lead and influence within complex organizations.
- Experience with risk management using a risk-based approach.
- Knowledge of evolving regulations and emerging technologies in the field.
- Strong experience in diagnostic design assurance and related regulatory pathways.