Associate Director, Quality Assurance (Medical Devices)

Location: Walkersville, Maryland, United States; office-based, Monday through Friday, 8:00 AM–5:00 PM EST

Salary: $168,000–$196,000 base annual salary, plus performance-related bonus

Company

hirify.global operates more than 30 sites across five continents and manufactures medicines and life-science products for customers worldwide.

What you will do

• Lead and develop a team of approximately 5–10 quality professionals.
• Oversee Quality Systems processes including change control, deviations, investigations, CAPA, complaints, effectiveness checks, document control, and label control.
• Ensure quality records are properly risk-assessed, investigated, reviewed, and closed with documented evidence.
• Monitor quality metrics, identify compliance risks, and establish governance and escalation processes for critical quality events.
• Partner with Quality, Manufacturing, Technical Operations, Regulatory Affairs, and site leadership on corrective actions and process improvements.
• Support internal audits, customer audits, regulatory inspections, inspection responses, departmental objectives, resource planning, and budgets.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Chemistry, Microbiology, or a related discipline; an advanced degree is preferred.
• 10+ years of Quality Assurance experience in pharmaceutical, biotechnology, medical device, cell therapy, or other regulated manufacturing environments.
• 5+ years of leadership experience managing Quality Systems functions and high-performing teams.
• Expertise in QMS processes including change control, deviations, investigations, CAPA, customer complaints, risk management, and compliance programs.
• Strong understanding of FDA, EU GMP, ISO 13485, and applicable cGMP/cGxP regulations.
• Experience with electronic QMS and validated systems such as TrackWise, MODA, and SAP, plus regulatory inspections, customer audits, and quality-system improvements.

Culture & Benefits

• Performance-related bonus.
• Medical, dental, and vision insurance.
• 401(k) matching plan.
• Life insurance and short-term and long-term disability insurance.
• Employee assistance programs and paid time off.
• Culture focused on collaboration, accountability, excellence, passion, integrity, compliance, and continuous improvement.