Quality Engineer - Validation (Medical Devices)

Location: Onsite in Buffalo Grove, Illinois, United States; up to 25% travel, including some international travel.

Salary: $85,000–$105,000 USD per year.

Company

hirify.global manufactures complex drug delivery systems and provides product development, industrialization, manufacturing, and contract manufacturing services for the pharmaceutical industry.

What you will do

• Plan, coordinate, and manage product, process, and equipment validations, including written protocols.
• Coordinate change control activities and resolve quality-system inefficiencies.
• Lead customer complaint investigations, corrective actions, and audit finding resolution.
• Apply CAPA, FMEA, DOE, SPC, cause-and-effect analysis, flow charts, and Six Sigma methods to quality problems.
• Evaluate supplier performance, conduct supplier quality audits, and support quality agreements.
• Develop specifications, analyze statistical data and inspection methods, and support FDA and ISO quality-system compliance.

Requirements

• Bachelor’s degree in engineering, science, or a related field.
• At least 3 years of experience in a quality position; medical-device experience with ISO 13485 is strongly preferred.
• Technical writing, IQ/OQ/PQ, and equipment-validation experience are preferred.
• Excellent English communication skills are required, including reading, writing, and speaking.
• Advanced mathematical and intermediate statistical knowledge, including SPC, is required.
• Onsite manufacturing experience and eligibility to work in the United States are required.

Nice to have

• Six Sigma training or certification.
• SAP and Microsoft Office experience.

Culture & Benefits

• Work in a clean manufacturing environment with moderate noise, PPE, and cleanroom apparel.
• Regular movement between office, production departments, and company buildings is required.
• Physical requirements include lifting up to 30 lbs, pushing and pulling items, and standing, sitting, or walking for up to 80% of a shift.
• Work within an international manufacturing group focused on improving patients’ lives through drug-delivery devices.