Quality Assurance Specialist (Medical Devices)

TL;DR

Quality Assurance Specialist (Medical Devices): Supporting and improving the quality management system for regulated medical device and in vitro diagnostic operations with an accent on regulatory compliance, document control, audits, and quality records. Focus on conducting internal audits, managing CAPA and change control activities, and maintaining inspection readiness across cross-functional manufacturing and engineering teams.

Location: Hybrid work schedule on-site in Billerica, Massachusetts, with travel between local U.S. facilities as needed.

Salary: $77,000–$86,000 per year.

Company

hirify.global develops scientific instruments and in vitro diagnostic solutions for biopharmaceutical and clinical applications, with FDA-registered and ISO-certified manufacturing operations.

What you will do

• Maintain and improve the QMS in line with regulatory requirements, industry standards, and internal procedures.
• Manage documents of external origin, controlled documents, quality records, SOPs, work instructions, forms, and templates.
• Conduct internal audits and support external audits and inspections, including evidence retrieval and finding closure.
• Support CAPA, nonconformance investigations, shipping holds, Engineering Change Orders, and Manufacturing Variances.
• Track quality deliverables, actions, due dates, equipment calibration, and preventive maintenance activities.
• Collaborate with Manufacturing, Engineering, Regulatory Affairs, Quality Control, Supplier Quality, Supply Chain, Technical Support, and R&D.

Requirements

• Bachelor’s degree in a scientific, technical, business, or related discipline preferred, or an equivalent combination of education and experience.
• 3–5 years of experience in Quality Assurance, Quality Systems, Regulatory Compliance, Document Control, or a related regulated-industry function.
• Experience supporting QMS activities, audits, change control, and compliance programs.
• Experience in medical devices, IVD, pharmaceuticals, biotechnology, or a similar regulated industry preferred.
• Ability to work on-site on a hybrid schedule in Billerica and travel between local U.S. facilities as needed.
• Ability to use required PPE, access manufacturing, warehouse, laboratory, and office environments, and lift up to 25 pounds.

Culture & Benefits

• Flexible medical, dental, and vision coverage.
• Competitive 401(k) company match, bonus program, generous paid time off, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Hybrid and flexible work arrangements.
• Employee engagement events and workplace meal benefits at Massachusetts and Maine offices.