Sr. Manager of Quality Assurance (Medical Devices)

Location: Pittsburgh, PA, United States — On Site

Salary: $140,000–$180,000 per year

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions.

What you will do

• Lead day-to-day quality assurance operations for a Class 3 PMA medical device manufacturing environment.
• Manage Quality Engineering and Inspection departments, including supervisors and engineering personnel.
• Maintain inspection and product release programs for incoming materials, in-process materials, and finished goods.
• Collect, analyze, and report quality metrics and trends to management.
• Liaise with external inspectors and auditors while ensuring audit and calibration schedules are met.
• Drive cross-functional resolution of complex quality issues and lead CAPA, risk management, change control, and PLM strategies.

Requirements

• Bachelor’s degree required; a master’s degree in Engineering or an MBA is preferred.
• Minimum of 7 years of management or leadership experience.
• At least 4 years of quality assurance engineering or related technical experience in medical device manufacturing is preferred.
• In-depth knowledge of 21 CFR 820, ISO 13485, ISO 14971, and European MDR requirements.
• Experience leading high-performing teams and applying Lean and Six Sigma methods, including process capability, Gage R&R, DOE, and DMAIC.
• Strong project management, data analysis, problem-solving, communication, and organizational skills.

Nice to have

• ASQ certification such as CQE, CRE, or CQM.
• Lean Six Sigma certification or additional experience.
• Master’s degree in Engineering or MBA.

Culture & Benefits

• Work in a medical technology environment focused on improving patient outcomes and saving lives.
• Join a fast-growing organization operating in more than 140 countries.
• Culture emphasizes innovation, self-motivation, entrepreneurial spirit, and continuous improvement.
• Comprehensive benefits plans are available.
• Physical work includes frequent standing, walking, lifting, carrying, pushing, pulling, and repetitive motions; the environment may include noise, temperature extremes, humidity, and wet conditions.