Quality Engineer - Manufacturing

AJR Enterprises, a UFP Technologies company, develops and manufactures single‑use safe patient handling systems, specializing in “cut and sew” manufacturing services and advanced fabric technologies. The role is based on‑site full‑time in St. Charles, IL, and candidates must reside within a 45‑minute commute. Applicants must be authorized to work in the United States; sponsorship is not available.

Responsibilities

• Lead compliance support for medical‑device manufacturing, including ID/traceability throughout the supply chain.
• Document and execute acceptance activities, non‑conforming material management, packaging/labeling control, and production/process controls.
• Conduct process validation, risk assessments, project meetings, pilot builds, first‑article inspections, and post‑market risk management.
• Design and implement methods and procedures for inspecting, testing, and evaluating product and equipment precision and accuracy.
• Develop and execute pFEMA’s, IQ, OQ, PQ, and PPQ validations.
• Manage corrective and preventive actions (CAPA), facilitate problem resolution, and own CAPA processes.
• Drive process improvement and support, including quality‑system review and revision.
• Provide training on quality‑system activities and requirements.
• Coordinate and facilitate internal and external audits.
• Perform other duties as needed.

Qualifications

• Bachelor’s degree in science, engineering, or equivalent.
• 3–7 years of relevant experience, with at least 3 years in medical‑device manufacturing.
• Strong knowledge of quality‑system policies and regulations (ISO 13485 and FDA 21 CFR 820).
• Experience conducting supplier audits and drafting supplier contracts.
• Familiarity with statistical analysis.

Benefits

• Medical, dental, vision, life, and disability insurance.
• 401(k) plan with matching contribution.
• Paid time off and paid holidays.
• Employee discounts and additional perks.

UFP Technologies, Inc. is an Equal Opportunity/Affirmative Action employer for minorities, women, veterans, and individuals with disabilities.