Quality Engineer

AJR Enterprises, a UFP Technologies company, is a leader in developing and manufacturing single use safe patient handling systems; specializing in 'cut and sew' manufacturing services and advanced fabric technologies.

Location: This position will be on-site full-time in St. Charles, IL.

Applicants must be authorized to work for any employer in the U.S. At this time, we are unable to sponsor or assume sponsorship of an employment visa.

This position ensures that the quality related engineering needs of the organization are met. Responsibilities include compliance and risk analysis, process validation, pFEMA’s, IQ, OQ, PQ and PPQ validation, CAPA and etc. The Quality Engineer works in collaboration with operations, supply chain, new product development teams.

• Leads in supporting compliance for medical device manufacturer in  / Traceability throughout supply chain, well documented and executed Acceptance Activities, Non-conforming material management, Packaging / Labeling control, Production / Process controls, and Process Validation.
• Conducts 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.
• Designs and executes pFEMAs and validations protocols including IQ, OQ, PQ and PPQ.
• Performs Corrective and Preventive Action management, facilitation, ownership and problem resolution.
• Drives process improvement and support, including Quality System process review and revision
• Provides training assistance, including providing training in quality system activities / requirements.
• Coordinates and Facilitates internal and external audit coordination and facilitation.
• Performs all other duties as assigned or needed.

• A bachelor’s degree in science, engineering or equivalent.
• 10 or more year’s relevant experience.
• At least 5 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.

UFP Technologies, Inc. is an Equal Opportunity/Affirmative Action employer Minorities/Women/Veterans/Disabled.