Quality Engineer

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 a leader in developing and manufacturing single use safe patient handling systems; specializing in 'cut and sew' manufacturing services and advanced fabric technologies.

UFP Technologies, Inc. offers a competitive benefits package, including but not limited to:

• Medical, Dental, Vision, Life, Disability Insurance
• 401K with a matching contribution
• Paid time off, Paid holidays, Employee discounts and much more!

Location: This position will be on-site full-time in St. Charles, IL. The position holder will need to be within commuting distance (within 45 min).

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.

Quality Engineer Summary

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. Position works in collaboration with operations, supply chain, new product development teams.

Quality Engineer Duties And 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.

Quality Engineer Qualification Requirements

• 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

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