Hybrid Design Quality Engineer – IVD (Newcastle)

EPM Scientific; Newcastle upon Tyne; Hybride; GBP 51 000 - 73 000; Plein temps

Résumé du poste

EPM Scientific is seeking a Design Quality Engineer to join a leading Diagnostics manufacturer on a long-term contract in Newcastle. This role requires hybrid on-site presence with responsibilities spanning design assurance, risk management, and regulatory submissions.

The position focuses on leading QA activities across the product lifecycle, ensuring compliance with 21 CFR 820, ISO 13485, IVDR, and related standards while coordinating with cross-functional teams for successful product launches

Qualifications

• Extensive experience in IVD medical device development and Design Controls.
• Strong working knowledge of regulated product development practices.
• Expert knowledge of international quality and regulatory standards (e.g., 21 CFR 820, ISO 13485, ISO 14971, IVDR).
• Ability to lead across complex matrix organisations and influence outcomes.

Responsabilités

• Lead Design Assurance and Design Quality Control across the product lifecycle.
• Serve as Design Control and Risk Management SME ensuring regulatory compliance.
• Provide QA leadership for development projects, regulatory submissions, design changes.
• Lead risk management to identify, evaluate, control, and monitor product risks.
• Develop, review, and approve design control deliverables (DHFs, risk docs, VER/VAL).
• Oversee QA for new product introductions, ensuring evidence and acceptance criteria.
• Support PMA, FDA 510(k), IVDR and other global submissions.
• Collaborate with Regulatory Affairs, R&D, Manufacturing, and external stakeholders.
• Assist inspections and audits by regulatory bodies as required.

Connaissances

IVD medical device development

Design Controls

Regulatory knowledge

Leadership in matrix orgs

Risk management

Description du poste

EPM Scientific is seeking a Design Quality Engineer to join a leading Diagnostics manufacturer on a long-term contract in Newcastle. This role requires hybrid on-site presence with responsibilities spanning design assurance, risk management, and regulatory submissions.

The position focuses on leading QA activities across the product lifecycle, ensuring compliance with 21 CFR 820, ISO 13485, IVDR, and related standards while coordinating with cross-functional teams for successful product launches