Mgr QA - Risk Management Process (Medical Devices)

Location: Hybrid, Northfield, Illinois, United States of America; travel up to 25% within the state, out of state, and/or internationally.

Salary: $116,000–$174,000 annual, plus bonus and/or incentive eligibility.

Company

hirify.global is a growing worldwide medical products organization offering quality, regulatory, and operational roles.

What you will do

• Manage quality and regulatory compliance for assigned products and processes across applicable product life cycles and distribution regions.
• Coordinate with divisions, suppliers, manufacturing, and operations to ensure product quality and customer satisfaction.
• Manage complaints, investigate quality issues, develop solutions, and ensure timely resolution.
• Identify and execute continuous improvement projects while coordinating design, testing, inspection, and process validation activities.
• Evaluate products from a quality assurance and regulatory compliance perspective.
• Lead day-to-day team operations, including hiring, performance reviews, training, work assignment, and policy implementation.

Requirements

• Bachelor’s degree in Engineering, Science, or a technical field, or relevant experience.
• At least 4 years of experience related to the design or operation of medical device or drug combination product platforms, design controls, and risk management in regulated industries.
• Experience working with QSR, GMP, ISO, 21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR requirements.
• Broad technical knowledge of relevant standards and regulations.
• Ability to analyze and report data to identify issues, trends, and exceptions and drive improvements.
• Ability to coordinate concurrent projects, competing priorities, and critical deadlines.
• Advanced Microsoft Excel skills, including functions, formatting, printing, and pivot tables.
• Ability to travel up to 25% for business purposes.

Nice to have

• At least 2 years of supervisory or managerial experience.
• Experience in the medical device, pharmaceutical, food, cosmetic, or personal products industries.

Culture & Benefits

• Full-time employment with health insurance, life and disability coverage, 401(k) contributions, and paid time off for employees working an average of at least 30 hours per week.
• Continuing education and training opportunities.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access.
• Inclusive workplace focused on belonging, diversity, career growth, and providing resources for effective work.