Quality Engineer, Manufacturing

Job overview

The Quality Engineer, Manufacturing role is onsite full-time in Saint Charles, IL, within commuting distance of the facility. Pay is $80,000–$100,000 per year. AJR Enterprises, a UFP Technologies company, develops and manufactures single-use safe patient-handling systems using cut-and-sew manufacturing services and advanced fabric technologies. The engineer ensures the organization meets quality-related engineering needs through compliance, risk analysis, validation, corrective and preventive action, and process improvement. The role works with operations, supply chain, and new product development teams to support medical-device quality systems.

What you'll do

• Support medical-device compliance for identification and traceability, acceptance activities, nonconforming material management, packaging and labeling controls, production and process controls, and process validation
• conduct risk assessments, project meetings, pilot builds, first-article inspections, and post-market risk management
• design inspection and testing methods
• execute pFMEA, IQ, OQ, PQ, and PPQ validation
• manage corrective and preventive actions
• improve quality-system processes
• assist with training
• and coordinate internal and external audits.

What we're looking for

Skills & competencies

quality engineer

manufacturing

medical devices

quality assurance

iso 13485

fda part 820

process validation

capa

saint charles il

ufp technologies

$80k–$100k

full-time onsite

401(k) match

paid time off

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, vision, life, and disability insurance
• 401(k) with matching contribution
• paid time off
• paid holidays
• and employee discounts.

Why this role

Requires a bachelor's degree in science, engineering, or equivalent; three to seven years of relevant experience, including at least three years in medical-device manufacturing; knowledge of ISO 13485 and FDA Part 820; and experience conducting supplier audits and writing supplier contracts. Visa sponsorship is not available.

About the employer

UFP Technologies is hiring for this role. Industry: Surgical Appliance and Supplies Manufacturing. Sector: 33.