Quality Engineer – Medical Devices & Process Validation

Ufp-Technologies; Saint Charles (MO); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401K with match

Paid time off

Paid holidays

Employee discounts

Job summary

AJR Enterprises, a UFP Technologies company, is seeking a Quality Engineer - Manufacturing to join our St. Charles, IL site. You will ensure quality engineering needs are met across operations, with focus on compliance, process validation, CAPA and vendor quality.

Responsibilities include risk analysis, IQ/OQ/PQ/PPQ validation, supplier audits, and collaboration with operations, supply chain and NPD teams to drive continuous improvement in a medical-device manufacturing environment.

Qualifications

• Bachelor's degree in science, engineering or equivalent.
• 3-7 years relevant experience
• At least 3 years’ experience in medical device manufacturing
• Strong knowledge of Quality Systems policies and regulations (ISO 13485 and FDA Part 820)
• Experience conducting supplier audits and writing supplier contracts
• Familiarity with statistical analysis

Responsibilities

• Support compliance for medical device manufacturing in ID/traceability across the supply chain.
• Manage acceptance activities, non-conforming material and packaging/labeling controls.
• Lead production/process controls and process validation (IQ/OQ/PQ/PPQ).
• Coordinate CAPA, risk assessments, audits and corrective actions.
• Collaborate with operations, supply chain and NPD teams.

Skills

Quality systems

Regulations

Statistical analysis

CAPA

Process validation

Risk assessment

Education

Bachelor's degree in science, engineering or equivalent

Job description

AJR Enterprises, a UFP Technologies company, is seeking a Quality Engineer - Manufacturing to join our St. Charles, IL site. You will ensure quality engineering needs are met across operations, with focus on compliance, process validation, CAPA and vendor quality.

Responsibilities include risk analysis, IQ/OQ/PQ/PPQ validation, supplier audits, and collaboration with operations, supply chain and NPD teams to drive continuous improvement in a medical-device manufacturing environment.