Operations Quality Manager (Medtech)

Location: Brooklyn Center, Minnesota, United States; onsite at least 5 days per week. Candidates must possess unrestricted U.S. work authorization at the time of hire and throughout employment; sponsorship is limited to Principal-level roles and above.

Salary: $142,400–$213,600 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops and manufactures medical technologies designed to alleviate pain, restore health, and extend life.

What you will do

• Lead quality operations for the Components Focus Factory, covering connectors and molding, capacitors, TDCO, and feedthroughs.
• Oversee quality programs, systems, processes, procedures, and ongoing compliance with internal and external standards.
• Drive timely nonconformance disposition and closure, CAPA documentation, root cause analysis, and corrective actions.
• Lead preparation for internal, external, customer, and regulatory audits and resolve inspection findings.
• Partner with operating entities and downstream hirify.global sites to investigate quality issues and implement solutions.
• Manage and develop engineers, supervisors, and technicians while driving standard work, Lean improvements, cost savings, and quality metrics.

Requirements

• Bachelor’s degree in engineering, science, or a technical field plus 5+ years of experience in engineering, quality, or a regulated industry; or an advanced degree plus 3+ years of experience.
• Experience with quality systems in a manufacturing environment, including process controls, inspection methods, validation, statistical analysis, and quality metrics.
• Experience with ISO 13485, FDA regulations, CAPA, nonconformance management, change control, and document control.
• Experience leading audits, preparing audit responses, addressing findings, and maintaining regulatory compliance.
• Proficiency with Lean, Six Sigma, continuous improvement, standard work, and operational performance improvement.
• Unrestricted U.S. work authorization is required; this role does not offer U.S. sponsorship. Degrees earned outside the United States must meet applicable U.S. H-1B educational requirements.

Culture & Benefits

• In-person collaboration and cross-functional exchanges are central to the work environment.
• Health, dental, and vision insurance, plus health and dependent-care spending accounts.
• Life insurance, disability coverage, paid time off, and paid holidays.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and incentive plans.
• Tuition assistance or reimbursement and a global well-being program.