Medical Device Quality Assurance Manager

As part of continued investment in their Medical Device and Combination Product portfolio, they are seeking an experienced Manager, Medical Device Quality Assurance to join their quality leadership team.

The Opportunity

This role will serve as a key quality partner supporting medical device and combination product programs throughout the product lifecycle, from development through commercialisation and post-market activities.

You will provide strategic quality oversight, support risk-based decision making, and ensure compliance with global regulatory and design control requirements. The position offers significant cross-functional exposure, working closely with R&D, manufacturing, regulatory affairs, suppliers, and commercial teams.

Key Responsibilities

• Provide quality oversight for medical device and combination product programs across development and commercial lifecycle activities.
• Act as a key quality representative within cross-functional teams, providing guidance on design controls, risk management, change control, supplier quality, and quality system requirements.
• Support sustaining activities including post-approval changes, manufacturing transfers, supplier changes, periodic product reviews, and product remediation initiatives.
• Assess quality, compliance, and patient safety impacts associated with product and process changes.
• Review and approve complaint investigations, ensuring robust technical assessments and timely resolution.
• Evaluate investigation outputs for completeness, root cause identification, risk assessment, and CAPA requirements.
• Partner with stakeholders to resolve complex quality and compliance challenges through practical, risk-based solutions.
• Monitor evolving regulatory requirements and support implementation of quality system improvements.
• Drive continuous improvement initiatives that enhance quality system maturity and operational effectiveness.
• Ensure alignment of quality policies and procedures across development, commercial, and sustaining activities.
• Support verification, validation, process validation, risk management, and ongoing lifecycle management activities.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Quality, or a related discipline.
• Experience within Quality Assurance in medical devices, combination products, pharmaceuticals, or another highly regulated industry.
• Strong understanding of Design Controls, Risk Management, and Quality Management Systems.
• Knowledge of ISO 13485, ISO 14971, FDA Quality System Regulations, and related global regulatory requirements.
• Experience supporting product development, design transfer, change control, and lifecycle management activities.
• Strong analytical skills with the ability to assess quality documentation, investigations, and quality system data.
• Proven ability to work effectively within complex cross-functional environments.
• Excellent communication, stakeholder management, and influencing skills.

Desirable Experience

• Experience across both pharmaceutical and medical device quality environments.
• Knowledge of combination product regulations and associated regulatory frameworks.
• Experience supporting supplier quality, vendor management, and external manufacturing partners.
• Expertise in complaint handling, post-market surveillance, CAPA, and product remediation programs.
• Experience supporting manufacturing transfers and post-market product changes.
• Understanding of verification, validation, usability engineering, process validation, and software-related quality activities.
• Experience applying risk-based decision making within product development and commercial environments.

Apply

If you are a Quality Assurance professional with experience supporting medical devices, combination products, or pharmaceutical products within a regulated environment, we'd welcome the opportunity to discuss this exciting career opportunity with you.