Quality Engineer - Medical Device Manufacturing

UFP Technologies, Inc.; St. Charles, Northern (IL, KY); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401K

Paid time off

Paid holidays

Employee discounts

Job summary

UFP Technologies, Inc. in St. Charles, IL, is seeking a Quality Engineer – Manufacturing to drive quality systems, compliance and process validation for a medical device manufacturing site.

The role offers an on-site, full-time position with a salary range of $80,000 to $100,000 per year and a competitive benefits package including medical, dental, vision, life and disability insurance, 401K, paid time off and holidays.

Qualifications

• Bachelor's degree in science, engineering or equivalent required.
• 3-7 years of relevant experience in medical device manufacturing preferred.
• Strong knowledge of ISO 13485 and FDA Part 820 quality systems.

Responsibilities

• Lead in supporting compliance for medical device manufacturer throughout the supply chain.
• Perform risk assessments and participate in CAPA, PFMEA, IQ/OQ/PQ/PPQ validation.
• Develop/inspect procedures for product and equipment quality checks.
• Support process controls, packaging/labeling, and production controls.
• Coordinate internal and external audits and supplier audits as needed.
• Drive continuous improvement and quality system updates.

Skills

Quality systems

Regulatory compliance

Statistical analysis

Process validation

CAPA

Education

Bachelor's degree in science or engineering

Job description

UFP Technologies, Inc. in St. Charles, IL, is seeking a Quality Engineer – Manufacturing to drive quality systems, compliance and process validation for a medical device manufacturing site.

The role offers an on-site, full-time position with a salary range of $80,000 to $100,000 per year and a competitive benefits package including medical, dental, vision, life and disability insurance, 401K, paid time off and holidays.