Quality Engineer - Medical Device Validation & Compliance

UFP Technologies; St. Charles (IL); On-site; USD 65,000 - 90,000; 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 in St. Charles, IL to support compliance and quality assurance for medical device manufacturing.

You will work with operations, supply chain and NPD teams to ensure risk management, process validation and CAPA are effectively implemented. Qualifications include a science/engineering degree and 3–7 years in medical device QA; experience with ISO 13485 and FDA Part 820 is required.

Qualifications

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

Responsibilities

• Lead compliance activities for medical device manufacturing across ID/Traceability and QA controls.
• Conduct risk assessments, pilot builds, First Article Inspections, and post-market risk management.
• Coordinate inspections, testing, and evaluation of products and production equipment.
• Design and execute pfEMAs, IQ/OQ/PQ/PPQ validations.
• Manage CAPA, root cause analysis and corrective actions.
• Coordinate internal and external audits.
• Train staff on quality system requirements.
• Support process improvement and quality system revisions.
• Collaborate with operations, supply chain, and NPD teams.

Skills

Quality systems knowledge

Medical device manufacturing

Supplier audits

Statistical analysis

Education

Bachelor's degree in science, engineering or equivalent

Job description

AJR Enterprises, a UFP Technologies company, is seeking a Quality Engineer in St. Charles, IL to support compliance and quality assurance for medical device manufacturing.

You will work with operations, supply chain and NPD teams to ensure risk management, process validation and CAPA are effectively implemented. Qualifications include a science/engineering degree and 3–7 years in medical device QA; experience with ISO 13485 and FDA Part 820 is required.