Quality Assurance Manager, Medical Device & Combination Products

Location: United Kingdom - Cambridge; hybrid work location assignment. Frequent business travel across hirify.global manufacturing sites, vendors, and suppliers may be required.

Company

hirify.global develops pharmaceutical, medical device, and combination products with a focus on safe and effective patient outcomes.

What you will do

• Provide quality oversight for medical device and combination product programs across development and sustaining lifecycle activities.
• Guide cross-functional teams on design controls, risk management, quality systems, vendor management, change control, and complaint activities.
• Support post-approval changes, supplier and component changes, manufacturing transfers, periodic product reviews, post-market surveillance, remediation, and obsolescence planning.
• Assess the quality, safety, and regulatory impact of product and process changes and maintain design and risk management documentation.
• Review and approve device complaint investigations, evaluating completeness, scientific rationale, issue linkage, risk alignment, closure timing, and CAPA relevance.
• Monitor global regulatory changes and drive improvements in quality policies, procedures, consistency, and quality system maturity.

Requirements

• Bachelor’s degree with at least 4 years of relevant experience, master’s degree with at least 2 years, PhD with 0+ years, associate’s degree with 8 years, or high school diploma with 10 years of relevant experience.
• Experience in quality assurance within medical devices, combination products, pharmaceuticals, GMP manufacturing, or another highly regulated industry.
• Working knowledge of design controls, risk management, quality systems, and applicable regulatory requirements.
• Experience supporting product development or sustaining lifecycle activities, including change control and ongoing product maintenance.
• Ability to make sound risk-based decisions in complex or ambiguous situations and collaborate effectively across functions.
• Strong communication, influencing, collaboration, analytical, documentation, systems, and data skills.

Nice to have

• Experience in both medical device and pharmaceutical quality environments, especially combination products.
• Experience with 21 CFR Part 4, post-market surveillance, complaint evaluation, periodic product review, remediation, suppliers, vendors, or external manufacturers.
• Familiarity with verification, validation, process validation, usability, software, or other technical development areas relevant to medical device programs.

Culture & Benefits

• Patient-centric environment focused on developing safe and effective products.
• Flexible workplace culture supporting work-life harmony.
• Values-led culture centered on courage, joy, equity, and excellence.
• Inclusive workplace with reasonable adjustments available for applicants with disabilities.
• Opportunities to contribute to digital transformation through data, modelling, and automated solutions.