Quality Manager (Medical Devices)

Location: Wilmington, MA

Salary: USD 105,000–135,000 per year

Company

hirify.global develops transformative engineering and industrial design solutions, including medical-device design and development services for clients.

What you will do

• Lead and continuously improve the ISO 13485:2016-certified Quality Management System and serve as Management Representative.
• Ensure design controls, design reviews, verification and validation, design transfer, and Design History Files are applied across development programs.
• Oversee risk management, internal and external audits, FDA inspections, management reviews, quality metrics, and regulatory compliance.
• Own CAPA, nonconformance, change control, document control, records management, and training processes.
• Manage supplier qualification, monitoring, audits, calibration, equipment maintenance, and validation activities during manufacturing transfer.
• Hire, develop, and manage the quality team while partnering with engineering, program management, clients, and manufacturing partners.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field; a Master’s degree is preferred.
• 7+ years of quality experience in the medical-device industry, including 3+ years in a design or product-development environment.
• 2+ years of people-management experience.
• Hands-on experience with ISO 13485, 21 CFR Part 820 (QMSR), ISO 14971, and design controls.
• Experience hosting FDA inspections and/or notified-body audits.
• Strong written and verbal communication, collaboration, decision-making, and problem-solving skills.
• Thorough, results-driven, organized, and effective at time management.

Nice to have

• Familiarity with IEC 62304, IEC 62366-1, and the IEC 60601-1 series.
• ASQ CQE, CQM/OE, or CBA certification, or ISO 13485 Lead Auditor certification.
• Master’s degree in Engineering, Life Sciences, or a related field.

Culture & Benefits

• Collaborative culture focused on continuous learning, mutual support, accountability, innovation, integrity, quality, and reliability.
• Flexible time off, sick leave, and bereavement leave.
• 401(k) plan with a company contribution of 3% of annual salary regardless of employee contributions.
• Medical, dental, and vision insurance, with the company covering 80% of monthly medical-plan premiums.
• Six weeks of fully paid parental leave with PFML state-program support.
• Regular social hours, athletic-club outings, and department events.