Manager, Quality Systems (Medical Devices)

TL;DR

Manager, Quality Systems (Medical Devices): Leading quality system initiatives, audit readiness, QMS compliance, and regulatory responses for medical device operations with an accent on FDA, ISO 13485, GMP, and continuous improvement. Focus on coordinating external audits, managing compliance risks, tracking corrective actions to closure, and improving quality processes across engineering, manufacturing, regulatory, and operations.

Location: Merrimack, New Hampshire, United States; site-based hybrid schedule with 1–2 days working from home

Salary: $115,000–$140,000 annually, plus 15% short-term incentive plan

Company

hirify.global develops medical technology and life science solutions for hospitals and healthcare institutions, serving customers in more than 135 countries.

What you will do

• Lead Quality Systems initiatives, including Management System Plans, audit programs, QMS updates, and compliance projects.
• Define project scope, deliverables, milestones, timelines, and resource requirements with Quality Systems and Program Management teams.
• Serve as Backroom Manager for FDA, Notified Body, customer, and other external audits.
• Coordinate audit logistics, documentation readiness, training, subject matter expert support, and post-audit commitments.
• Track quality project risks, escalations, observations, and corrective actions through resolution.
• Partner with Quality, Regulatory, Engineering, Manufacturing, Operations, and global functions to improve quality processes and tools.

Requirements

• Bachelor’s degree in engineering or science, or equivalent experience.
• At least seven years of experience in medical devices, pharmaceuticals, or another regulated industry.
• Experience managing Quality Systems elements, audits, regulatory inspections, and compliance initiatives.
• Strong knowledge of QMS requirements, FDA regulations including 21 CFR Parts 820 and 11, ISO 13485, GMP, and applicable global standards.
• Ability to manage complex projects, drive continuous improvement, correct deficiencies, and prevent recurrence through closure.
• Strong communication, analytical, organizational, problem-solving, and prioritization skills; advanced Microsoft Office and ERP experience, such as SAP.

Nice to have

• Certified Quality Auditor, Six Sigma, or similar certification.
• Experience serving as an audit Backroom Manager or lead.

Culture & Benefits

• Manage and develop a small team of engineering and quality professionals.
• Health, dental, and vision insurance with 401(k) company match.
• Paid time off, parental and caregiver leave, life insurance, and disability benefits.
• Wellness resources, flexible spending accounts, commuter benefits, and tuition reimbursement.
• Work in a regulated medical technology environment focused on improving clinical outcomes and healthcare workflows.