Quality Engineer – Medical Device Manufacturing

UFP Technologies, Inc.; St. Charles (IL); Vor Ort; USD 85.000 - 110.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, Vision, Life, and Dis

401K with matching

Paid time off

Zusammenfassung

UFP Technologies, Inc. in St. Charles, IL is seeking a Quality Engineer to support compliance, CAPA, and process validation across the supply chain.

The role collaborates with operations, supply chain, and new product development teams to ensure quality systems and regulatory requirements are met. The ideal candidate has 3–7 years in medical device manufacturing, strong QA knowledge, and hands-on experience with IQ/OQ/PQ/PPQ validation and risk management.

Qualifikationen

• Bachelor's degree in science or engineering or equivalent.
• 3–7 years of relevant experience in medical device manufacturing.
• 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.

Aufgaben

• Lead in supporting compliance for medical device manufacturer in ID/Traceability throughout supply chain, well documented and executed Acceptance Activities, Non-conforming material management, Packaging/Labeling control, Production/Process controls, Process Validation.
• Risk Assessments, project meetings, pilot builds, First Article Inspections, and Post Market Risk Management
• Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment
• Design and execution of pfMEAs, IQ, OQ, PQ and PPQ validation
• Corrective and Preventive Action management, facilitation, ownership and problem resolution
• Process improvement and support, including Quality System process review and revision
• Training assistance, including providing training in quality system activities/requirements
• Internal and external audit coordination and facilitation
• Performs all other duties as needed.

Kenntnisse

Quality systems

Statistical analysis

Supplier audits

Ausbildung

Bachelor's degree in science or engineering

Jobbeschreibung

UFP Technologies, Inc. in St. Charles, IL is seeking a Quality Engineer to support compliance, CAPA, and process validation across the supply chain.

The role collaborates with operations, supply chain, and new product development teams to ensure quality systems and regulatory requirements are met. The ideal candidate has 3–7 years in medical device manufacturing, strong QA knowledge, and hands-on experience with IQ/OQ/PQ/PPQ validation and risk management.