Quality Systems Specialist – Affera Software (Medical Device Software)

Location: Onsite in Mounds View, Minnesota, United States; minimum four days per week onsite. Travel is less than 20%.

Salary: $75,200–$112,800 per year, plus eligibility for a short-term incentive plan.

Company

hirify.global develops medical technologies intended to alleviate pain, restore health, and extend life, serving patients across more than 150 countries.

What you will do

• Support quality system execution for Affera software products within the Cardiac Ablation Solutions operating unit.
• Coordinate software-related CAPAs, including owner education, action tracking, documentation review, implementation support, and effectiveness verification.
• Support field corrective actions through action coordination, evidence collection, follow-up, and status tracking.
• Maintain audit and inspection readiness for CAPA records, field actions, procedures, metrics, and objective evidence.
• Track software and security CAPA metrics, quality system deliverables, action closure, and other quality indicators for weekly reporting and management reviews.
• Partner with Quality, R&D, Regulatory, Medical Safety, Product Security, Customer Quality, Field Quality, and Enterprise teams to improve compliant execution.

Requirements

• Bachelor’s degree and 2+ years of relevant experience, or an advanced degree with 0+ years of relevant experience.
• Experience coordinating multiple deliverables, tracking action items, and supporting timely completion of quality system activities.
• Strong written and verbal communication skills, including preparation or review of controlled documentation.
• Ability to interpret procedures and apply quality system requirements to daily execution.
• Knowledge of regulated quality and software standards such as FDA 21 CFR Part 820, ISO 13485, IEC 62304, IEC 62366, 21 CFR Part 11, EU MDR, or software cybersecurity guidance is preferred.
• Roles below the Principal level require unrestricted U.S. work authorization at the time of hire and throughout employment; U.S. sponsorship is not available for this role.

Nice to have

• Experience in medical devices, pharmaceuticals, biotechnology, or another regulated quality-system industry.
• Experience with CAPA programs, root-cause investigations, corrective actions, effectiveness verification, audit readiness, or audit finding closure.
• Experience with TrackWise, Agile PLM, Jira, or similar quality and product lifecycle tools.
• Experience developing quality metrics, dashboards, or KPI reports.

Culture & Benefits

• Regular employee position with health, dental, and vision insurance.
• Health Savings Account, Healthcare Flexible Spending Account, life insurance, and disability coverage.
• Paid time off, paid holidays, retirement plans with employer contribution and match, and incentive plans.
• Tuition assistance or reimbursement, employee stock purchase plan, employee assistance program, and global well-being resources.