Quality Project Manager (Medical Devices)

Location: Buffalo Grove, Illinois, United States; onsite work in office, production, and clean room environments with travel between company buildings.

Salary: $120,000–$140,000 USD per year, salaried.

Company

hirify.global is a global manufacturer of complex drug delivery systems for the pharmaceutical industry, developing and manufacturing inhalation, injection, nasal, dermal, and ophthalmic delivery devices.

What you will do

• Coordinate quality goals and initiatives that improve product quality and operating system efficiency.
• Direct and coordinate Quality Department activities and supervise staff, including hiring, training, task management, performance evaluation, and conflict resolution.
• Maintain quality systems and ensure compliance with ISO, cGMP, FDA, Health & Safety, customer, and internal requirements.
• Manage claims, non-conformities, investigations, root cause analysis, CAPA, and sustainable corrective actions.
• Own the change control process and manage process, equipment, and product validations.
• Represent Quality in customer, ISO, and third-party audits while collaborating with production, technology, supply chain, metrology, QC, and compliance teams.

Requirements

• Bachelor’s degree in Engineering or a related field.
• 4+ years of relevant Quality experience in a manufacturing environment, including 1+ year in a supervisory role.
• Ability to understand, read, write, and speak English.
• Advanced mathematical concepts and intermediate statistical process control knowledge.
• Strong understanding of injection molding, automation, FMEA, and equipment, process, and product validation practices.
• Ability to lift up to 30 lbs., push and pull items, and sit, stand, or walk for 80% of the shift.

Nice to have

• Medical device or pharmaceutical industry experience.
• Six Sigma training or certification.
• Knowledge of inspection tool design, use, repair, and maintenance.
• Knowledge of business and management principles, Microsoft Word, Excel, database software, and SAP.

Culture & Benefits

• Work in an international manufacturing group with sites across the United States, France, Germany, Brazil, and Poland.
• Office and clean room work environments with appropriate PPE and cleanroom apparel.
• Work focused on improving patient lives through reliable drug delivery devices.
• US employee benefits are provided.