Quality Systems Program Manager (Medtech)

TL;DR

Quality Systems Program Manager (Medtech): Leading the strategy, governance, and execution of Quality System programs across manufacturing sites with an accent on QMS effectiveness and regulatory alignment. Focus on CAPA governance, audit strategy, and ensuring sustainable systemic improvements across the campus quality landscape.

Location: Onsite in Minneapolis, Minnesota, USA (minimum 5 days a week)

Salary: $120,000 - $180,000

Company

hirify.global is a global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through engineering and innovation.

What you will do

• Drive the overall strategy and execution of Quality Systems across Twin Cities Campus manufacturing sites to align with global standards.
• Partner with site Quality leadership to develop a roadmap that strengthens compliance and operational effectiveness.
• Provide governance and oversight for the CAPA program, ensuring effective root cause analysis and systemic improvements.
• Lead the development of site audit strategies and ensure a constant state of regulatory inspection readiness.
• Facilitate cross-site collaboration to standardize quality system processes and share best practices.
• Develop and track key performance indicators (KPIs) to provide status updates and risk assessments to leadership.

Requirements

• Bachelor's Degree with 5+ years of experience in Quality or a regulated industry, OR an Advanced Degree with 3+ years of experience.
• Must possess unrestricted U.S. work authorization (Sponsorship is only available for Principal-level roles).
• Commitment to work onsite in Minneapolis, MN.

Nice to have

• Expertise in QMS Strategy, Governance, and Continuous Improvement.
• Strong knowledge of FDA and global regulatory compliance.
• Experience in enterprise program management for multi-site initiatives.
• Background in operational excellence within regulated manufacturing.

Culture & Benefits

• Competitive salary and short-term incentive plan (MIP).
• Comprehensive Health, Dental, and Vision insurance, including HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and an Employee Stock Purchase Plan.
• Tuition assistance/reimbursement and a global well-being program (Simple Steps).