Quality Associate II - Onsite Weekdays (Medical Devices)

Location: Medina, New York, United States; onsite role with an encouraged presence of five days per week and regular in-person support required

Salary: $88,000–$121,500 annually, plus potential discretionary bonuses

Company

hirify.global develops healthcare products and solutions with a mission to save and sustain lives.

What you will do

• Maintain and improve the site Quality Management System in accordance with FDA regulations, ISO 13485, Canadian medical device regulations, and hirify.global policies.
• Manage internal and external audits, including planning, hosting, reporting, responses, corrective actions, and closure.
• Lead audit readiness, site compliance programs, certifications, registrations, and internal auditor qualification.
• Develop, review, and update Standard Operating Procedures and provide quality compliance training and coaching.
• Analyze Quality Management System KPIs, support management reviews, and drive quality improvement activities.
• Coordinate records management, including indexing, storage, retrieval, legal holds, retention reviews, and approved destruction.

Requirements

• Bachelor’s degree required; a master’s degree in science or engineering is a plus.
• At least 3 years of quality experience involving regulatory oversight and compliance, preferably in medical devices, pharmaceuticals, or another regulated industry.
• Experience interpreting quality system regulations and knowledge of FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, risk management, root cause analysis, CAPA, and document control.
• Experience with quality and root cause analysis tools, statistical methods, Microsoft Office, project management, and concurrent priorities.
• Strong written and verbal communication, problem-solving, conflict-resolution, organization, and attention-to-detail skills.
• Must reside within reasonable commuting distance of Medina, New York, work regularly onsite, and already be authorized to work for any U.S. employer.

Culture & Benefits

• Collaborative, accountable environment focused on courage, trust, ownership, and continuous improvement.
• FDA-regulated manufacturing workplace with required protective smocks and PPE in designated areas.
• Medical and dental coverage beginning on the first day, plus life, disability, and travel accident insurance.
• 401(k) plan with company matching, employee stock purchase plan, flexible spending accounts, and educational assistance.
• Paid holidays, 20–35 days of paid time off based on tenure, family and medical leave, and paid parental leave.