Design Quality Assurance Manager (Medical Devices)

Location: Milwaukee Design Center, Wauwatosa, Wisconsin, United States. Full-time onsite role with 30% travel.

Company

hirify.global provides healthcare technology and medical device services.

What you will do

• Lead quality oversight for new medical device product development and ensure compliance with applicable regulatory and quality system requirements.
• Partner with R&D on design planning, design inputs and reviews, verification, validation, transfer, and Design History File maintenance.
• Review and approve design and development documentation for completeness, accuracy, and regulatory alignment.
• Own the ISO 14971 risk management process, including hazard analysis, FMEA, usability risk, and risk controls.
• Guide design-for-quality, reliability engineering, human factors engineering, test method development, and design change control.
• Serve as a subject matter expert during audits and inspections while leading, coaching, and mentoring Design Quality Engineers.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, or related Engineering discipline.
• 5–10 years of experience in medical device quality assurance, quality engineering, or regulatory compliance for FDA Class I and II devices.
• At least 3 years in a Senior or Principal Design Quality role with direct or indirect supervisory responsibility.
• At least 1 year of CAPA ownership experience in a design and development environment.
• Expertise in design controls, product development processes, software-embedded medical devices, and risk management.
• Experience with FDA QSR, ISO 13485, MDSAP, ISO 14971, IEC 60601, IEC 62366, IEC 62304, and EU MDR.

Nice to have

• Advanced degree in a relevant discipline.

Culture & Benefits

• Cross-functional collaboration across R&D, Manufacturing, Operations, and Supplier Quality.
• Focus on proactive quality, accountability, continuous improvement, and patient safety.
• Health, dental, and vision insurance options, disability coverage, life insurance, and flexible spending and health savings accounts.
• Paid time off, 401(k) plan with employer match, tuition reimbursement, employee discounts, wellness programs, and an employee assistance program.
• Vaccination requirements may apply based on customer or company requirements; required vaccination expenses are covered at participating clinics.