Quality Systems Specialist (Affera Software)

TL;DR

Quality Systems Specialist (Affera Software): Supporting quality system execution for Affera software products with an accent on software-related CAPAs, field corrective actions, compliance, and audit-ready quality system records. Focus on interpreting regulatory requirements, tracking quality metrics, and coordinating cross-functional resolution of software quality system issues in a regulated medical device environment.

Location: Mounds View, Minnesota, United States of America (onsite, minimum 4 days/week)

Salary: $75,200.00 - $112,800.00 (USD)

Company

hirify.global is a global healthcare technology company developing medical technologies to improve patients’ lives.

What you will do

• Lead ongoing audit and inspection readiness for software quality system areas, including CAPA records, field action records, metrics, procedures, and objective evidence.
• Interpret policies and regulatory/internal requirements to ensure compliance and provide guidance to stakeholders.
• Support execution of software-related CAPAs, including CAPA owner organization/education, action tracking, documentation review, and verification of effectiveness.
• Support field corrective action execution for Affera software, including coordination, follow-up, evidence collection, and status tracking.
• Maintain and track metrics for software and security CAPAs/field actions and prepare weekly reports and management review inputs.
• Support review and updates of quality system records for completeness, consistency, traceability, and compliance; assist with closure of audit findings and corrective/preventive actions.

Requirements

• Bachelor’s degree and at least 2 years of relevant experience, or advanced degree with 0 years of relevant experience.
• Experience working in a regulated environment and/or with quality system execution and compliance activities.
• Working knowledge of medical device quality system requirements and standards, including FDA 21 CFR 820, ISO 13485, IEC 62304, IEC 62366, 21 CFR Part 11, EU MDR, and related guidance/requirements.
• Experience supporting CAPA activities (root cause investigation, CAPA planning, execution tracking, and verification of effectiveness).
• Ability to interpret procedures and regulatory requirements and apply them to practical quality system execution.
• Ability to work onsite at least 4 days per week in Mounds View, Minnesota.

Culture & Benefits

• Onsite collaboration with a minimum of 4 days/week onsite.
• Eligible for a short-term incentive (hirify.global Incentive Plan, MIP).
• Health, dental, and vision insurance plus Health Savings Account and Healthcare Flexible Spending Account (for regular employees working 20+ hours/week).
• 401(k) plan with employer contribution and match, paid time off, paid holidays, and employee assistance program (for regular employees).
• Tuition assistance/reimbursement and global well-being program (Simple Steps).

Hiring process

• Application review and screening based on required qualifications and regulated-quality systems experience.
• Interviews with cross-functional stakeholders to assess compliance discipline, technical judgment, and ability to manage multiple quality deliverables.