Quality Assurance Manager, Medical Device & Combination Products

Location: Kalamazoo, Michigan, United States; hybrid work arrangement. Permanent U.S. work authorization is required.

Annual base salary: $99,200–$165,400; Tampa, Florida range: $89,400–$149,000. The role is also eligible for a 12.5% bonus target and a share-based long-term incentive program.

Company

hirify.global develops and supplies medicines and healthcare products with a focus on product quality, patient safety, and regulatory compliance.

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.
• Assess the quality, safety, and regulatory impact of product and process changes, including supplier changes, manufacturing transfers, and post-approval changes.
• Review and approve device complaint investigations, evaluating technical rigor, documentation, risk alignment, and CAPA relevance.
• Support post-market surveillance, periodic product reviews, product remediation, obsolescence planning, and lifecycle management.
• Monitor regulatory changes and drive improvements in quality processes, policies, and 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 product maintenance.
• Strong analytical, communication, influencing, collaboration, and risk-based decision-making skills.
• Permanent U.S. work authorization is required; U.S. work visa sponsorship is not available.

Nice to have

• Experience across both medical device and pharmaceutical quality environments, especially combination products.
• Knowledge of combination product regulations, including 21 CFR Part 4, and broader medical device regulatory expectations.
• Experience with 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.

Culture & Benefits

• Hybrid work arrangement with frequent business travel to hirify.global manufacturing sites, vendors, and suppliers.
• Annual bonus target of 12.5% and eligibility for a share-based long-term incentive program.
• 401(k) plan with hirify.global matching and additional retirement savings contributions.
• Paid vacation, holidays, personal days, caregiver and parental leave, and medical leave.
• Medical, prescription drug, dental, and vision coverage.