Quality Engineer - Medical Device Manufacturing & Validation

Socket.dev; St. Charles (IL); On-site; USD 70,000 - 100,000; Full time

Job summary

UFP Technologies, Inc. is seeking a Quality Engineer to ensure quality engineering needs are met across manufacturing. You will handle compliance activities including device traceability, CAPA, and process validation, working with operations, supply chain, and new product development teams.

The role requires a Bachelor's degree in science or engineering, 3–7 years of medical device experience, and strong knowledge of ISO 13485 and FDA 820. On-site in St.

Qualifications

• A Bachelor's degree in science, engineering or equivalent.
• 3-7 year’s 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) with a strong background in medical device quality assurance and processes.
• Experience conducting supplier audits and writing supplier contracts.
• Familiarity with statistical analysis.

Responsibilities

• 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 pFEMA’s, 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.

Skills

Quality systems

Statistical analysis

Supplier audits

CAPA management

Process validation

Education

Bachelor's degree in science/engineering

Job description

UFP Technologies, Inc. is seeking a Quality Engineer to ensure quality engineering needs are met across manufacturing. You will handle compliance activities including device traceability, CAPA, and process validation, working with operations, supply chain, and new product development teams.

The role requires a Bachelor's degree in science or engineering, 3–7 years of medical device experience, and strong knowledge of ISO 13485 and FDA 820. On-site in St.