Senior Quality System Manager (MedTech)

TL;DR

Senior Quality System Manager (MedTech): Providing strategic leadership for the Quality Management System (QMS) and overseeing the CAPA program within the Neuromodulation Operating Unit with an accent on regulatory compliance and continuous improvement. Focus on driving governance, managing change control, and ensuring alignment with FDA and ISO 13485 standards.

Location: Onsite in Rice Creek/Fridley, MN (working onsite 4 days a week)

Salary: $149,600 - $224,400 USD

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical technologies.

What you will do

• Provide strategic and operational leadership for the Quality Management System (QMS) and continuous improvement initiatives.
• Lead the governance and oversight of the CAPA program to ensure timely execution and regulatory compliance.
• Oversee core quality system processes, including change control, training, management review, and quality metrics.
• Monitor system performance and identify trends to drive improvements via data-driven decision making.
• Partner cross-functionally to ensure quality processes support business objectives and regulatory requirements.
• Support internal and external audits, regulatory inspections, and remediation activities.

Requirements

• Must be based in or able to work onsite in Fridley, MN (4 days a week).
• Bachelor’s degree with 7+ years in Quality Systems within the medical device industry OR advanced degree with 5+ years.
• Minimum of 5+ years of people management experience.
• Unrestricted U.S. work authorization is required (Sponsorship is only offered for Principal-level roles and above).

Nice to have

• Strong understanding of FDA QMSR, ISO 13485, and European Medical Device Regulation.
• Proven experience leading CAPA processes, including root cause analysis and effectiveness verification.
• Experience using structured methodologies to support fact-based decision-making.
• Ability to influence stakeholders and communicate effectively across all organizational levels.

Culture & Benefits

• Competitive base salary and eligibility for the hirify.global Incentive Plan (MIP).
• Comprehensive health, dental, and vision insurance, including HSA and Healthcare FSA.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and a global well-being program (Simple Steps).
• Tuition assistance/reimbursement and Employee Stock Purchase Plan.