Director, Quality Assurance and Vigilance (MedTech)

Location: North Andover, Massachusetts, United States; hybrid with onsite work three days per week. Applicants must be authorized to work for any employer in the United States. Visa sponsorship is not available now or in the future.

Salary: $185,000–$205,000 per year, plus eligibility for a bonus plan targeting 16% of base salary.

Company

hirify.global develops and supports medical-device products and solutions within the MedTech business.

What you will do

• Lead and develop the North Andover Design Center Quality organization, serving as Site Quality Management Representative.
• Own and maintain the site Quality Management System, including document control, training, audits, CAPA, change control, and management reviews.
• Govern design controls, verification and validation, risk management, design reviews, design changes, and design transfer to manufacturing.
• Lead Design for Excellence activities covering manufacturability, assembly, serviceability, reliability, safety, and cost.
• Oversee supplier quality activities, quality planning for new product development, and quality support for manufacturing and post-market investigations.
• Prepare the site for FDA inspections, Notified Body audits, corporate audits, and internal audits while driving continuous improvement and quality culture.

Requirements

• More than 10 years of relevant experience, including at least 5 years managing individuals.
• Deep expertise in Design Assurance, Design Transfer, DfX, supplier management, and medical-device quality systems.
• Strong knowledge of 21 CFR Parts 11 and 820, ISO 13485, ISO 9001, ISO 14971, QSR, MDSAP, and EU MDR requirements.
• Demonstrated experience with FDA inspections and Notified Body audits.
• Ability to lead teams, influence change, communicate with diverse stakeholders, and solve quality problems pragmatically.
• Effective spoken and written English is required, along with authorization to work for any employer in the United States.

Nice to have

• Experience with infusion pumps, sets, and systems.
• ASQ or RAPS certification.

Culture & Benefits

• Hybrid work arrangement with three onsite days per week.
• Medical, prescription drug, dental, and vision coverage.
• 401(k) plan with company contributions.
• Paid vacation, holidays, personal days, life insurance, disability coverage, wellness program, and employee assistance program.
• Quality culture focused on right-first-time execution, zero defects, early escalation, continuous learning, and patient safety.