Design QA Contractor

EPM Scientific; Newcastle upon Tyne; Hybrid; GBP 51,000 - 73,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

IVD medical device development

Design Controls

Regulatory knowledge

Leadership in matrix orgs

Risk management

Job description

Seeking a Design Quality Engineer to join a leading Diagnostics manufacturer on a long term contract.

This is an ASAP start project running through till at least end of 2027. Hybrid on site presence in Newcastle is required.

Outside IR35 paying up to 45 GBP per hour.

Major Responsibilities

• Lead Design Assurance and Design Quality Control activities across the product lifecycle, including development, commercialization, design transfer, and sustainment.
• Serve as the Design Control and Risk Management subject matter expert, ensuring compliance with applicable regulatory and quality requirements.
• Provide Quality Assurance leadership for product development projects, regulatory submissions, design changes, and complex investigations.
• Lead risk management activities, ensuring product risks are appropriately identified, evaluated, controlled, and monitored throughout the product lifecycle.
• Develop, review, and approve key design control deliverables, including quality plans, risk management documentation, verification and validation documentation, and Design History Files (DHFs).
• Provide Design Quality Control oversight for new product introductions, ensuring robust quality evidence, acceptance criteria, verification and validation outcomes, and design transfer readiness.
• Support Pre-Market Approval (PMA), FDA 510(k), IVDR, and other global regulatory submissions.
• Partner with Regulatory Affairs, R&D, NPI, Manufacturing, and external stakeholders to support inspections, audits, product approvals, and commercialization activities.
• Support interactions with regulatory agencies and notified bodies as required.

Additional Responsibilities

• Drive continuous improvement and effective application of QMS processes and DBS principles.
• Provide technical leadership, coaching, and mentoring to colleagues and project teams.
• Influence stakeholders through expert judgement and risk-based decision making.
• Maintain expertise in evolving regulations, standards, guidance documents, and emerging technologies.
• Foster effective stakeholder engagement and cross-functional collaboration.

Required Skills/Experience/Education

• 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, including: 21 CFR 820, ISO 13485, ISO 14971, MDSAP, IVDR knowledge and practical experience strongly preferred.
• Demonstrated ability to:
• Provide leadership across complex matrix organisations and influence organisational outcomes.
• Manage and mitigate risk using a risk based approach
• Influence senior stakeholders without direct authority

Desired Skills and Experience

Design Quality, IVDR, IVD, Diagnostic, Design Assurance, Design Control, Risk Management, DHF