Design Quality Lead

Design Quality LeadRole Summary

The Design Quality Lead is responsible for leading the Design Quality function at a manufacturing site. This role has primary ownership of product risk management activities, including the development, maintenance, and governance of risk management files.

The position provides end-to-end Quality Engineering support across New Product Development (NPD) and New Product Introduction (NPI), ensuring compliance with all regulatory requirements and internal quality systems. The role is critical in driving quality excellence across the product lifecycle and aligning quality objectives with site and organisational goals.

Key Responsibilities

• Lead, mentor, and develop a team of Quality Engineers, including hiring, performance management, and capability development
• Ensure compliance with all applicable regulatory standards and quality system requirements
• Plan and allocate Quality Engineering resources across NPD and NPI programs
• Provide technical leadership in:
• Test method validation
• Product verification and validation
• Reliability testing
• Statistical analysis
• Oversee:
• Component qualification
• Process capability analysis
• Equipment qualification
• Process validation
• Own and drive risk management processes, ensuring robust risk assessments and maintenance of risk files
• Support post-market activities, including field investigations and surveillance
• Partner with cross-functional teams (R&D, Engineering, Operations) to support product development and successful product launches
• Review and approve validation documentation and risk management deliverables
• Lead and support internal, regulatory, and third-party audits
• Contribute to regulatory submissions and continuous improvement initiatives

Candidate ProfileQualifications

• Degree in Engineering, Science, or a related technical discipline

Experience

• Minimum 5+ years’ experience in Class II or Class III medical devices
• At least 3 years’ experience in a people leadership or supervisory role
• Proven experience in highly regulated environments (medical devices, pharmaceutical, or life sciences)

Technical Expertise

• Strong working knowledge of:
• QSR, ISO 13485, ISO 14971
• MDD/MDR, MDSAP
• 21 CFR and relevant ICH guidelines
• Hands-on experience with:
• Design, process, equipment, test method, and software validation
• Risk management and root cause analysis methodologies
• Statistical techniques, sampling plans, and process capability
• Experience supporting new product development and commercialization
• Track record in audit readiness and execution

Key Skills & Competencies

• Strong leadership and team development capabilities
• Results-oriented with a high level of ownership and accountability
• Effective decision-making in complex and fast-paced environments
• Strong stakeholder engagement and influencing skills
• Excellent communication and presentation abilities
• Analytical mindset with strong problem-solving skills
• Ability to manage competing priorities and deliver to timelines
• Adaptable, proactive, and focused on continuous improvement

Work Environment

This role requires a predominantly on-site presence to support collaboration, innovation, and operational effectiveness. Some flexibility may be available depending on business needs.

Equal Opportunity Statement

Our client is an equal opportunity employer and is committed to fostering an inclusive and diverse workplace. All qualified applicants will be considered without regard to legally protected characteristics.