Quality Engineer I - Manufacturing (Medical Devices)

Location: Onsite in Allentown, Pennsylvania, United States. Regular and predictable attendance is required; occasional business travel is also required.

Salary: $85,300–$95,300 per year

Company

hirify.global develops, manufactures, and markets medical products and services for infusion therapy, pain management, nutrition, pharmacy compounding, ostomy and wound care, and dialysis.

What you will do

• Provide quality support for materials, products, manufacturing processes, and test methods.
• Investigate nonconformances, CAPAs, complaints, and quality trends using root cause analysis.
• Represent Quality in material review board meetings and execute quality improvement change controls.
• Develop risk assessments and action plans to mitigate impacts on quality and production KPIs.
• Lead equipment installation and qualification activities, as well as test method validation.
• Establish quality standards, audit production processes and suppliers, and collaborate with design, product management, and production teams.

Requirements

• At least 2 years of related experience.
• Bachelor’s degree.
• Knowledge of professional quality practices, principles, and procedures.
• Ability to resolve day-to-day quality problems under general supervision.
• Ability to sit, stand, walk, talk, hear, handle materials, and occasionally lift or move up to 20 pounds.

Nice to have

• Applicable industry or professional certification.

Culture & Benefits

• Healthcare benefits.
• 401(k) plan.
• Tuition reimbursement.
• Continuous improvement supported through the Sharing Expertise initiative.
• Work focused on safety, efficiency, sustainability, and improving healthcare products and services.