Quality Assurance Manager, Medical Device & Combination Products

TL;DR

Quality Assurance Manager, Medical Device & Combination Products (Medical Devices/Combination Products): Providing quality oversight for medical device and combination product development, sustaining, and complaint activities with an accent on design controls, risk management, and regulatory compliance. Focus on reviewing complex complaint investigations, assessing product and process changes, and strengthening quality systems across the product lifecycle.

Location: Hybrid role based in Sandwich, United Kingdom; frequent business travel to hirify.global manufacturing sites, vendors, and suppliers may be required.

Company

hirify.global is a global pharmaceutical company focused on developing and delivering medicines and healthcare products that improve patient outcomes.

What you will do

• Provide quality oversight for medical device and combination product development and sustaining programs.
• 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, product reviews, post-market surveillance, and remediation planning.
• Assess the quality, safety, and regulatory impact of product and process changes.
• Review and approve device complaint investigations, ensuring technical rigor, complete documentation, risk alignment, and timely closure.
• Monitor evolving global regulations and drive improvements in policies, procedures, and quality system practices.

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 medical device or pharmaceutical regulations.
• Experience supporting product development or sustaining lifecycle activities, including change control and product maintenance.
• Strong analytical, communication, influencing, collaboration, and risk-based decision-making skills.

Nice to have

• Experience across both medical device and pharmaceutical quality environments, particularly combination products.
• Knowledge of 21 CFR Part 4, 21 CFR 820, ISO 13485, ISO 14971, post-market surveillance, complaint evaluation, and periodic product review.
• Experience with supplier and external manufacturer partnerships, manufacturing transfers, verification, validation, process validation, usability, or software development.

Culture & Benefits

• Patient-centric environment guided by courage, joy, equity, and excellence.
• Flexible workplace culture supporting work-life harmony.
• Commitment to diversity, inclusion, accessibility, and reasonable workplace adjustments.
• Opportunity to contribute to digital transformation through data, modeling, and automation initiatives.