Quality Engineer – Manufacturing

UFP Technologies, Inc.; St. Charles, Northern (IL, KY); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401K

Paid time off

Paid holidays

Employee discounts

Job summary

UFP Technologies, Inc. in St. Charles, IL, is seeking a Quality Engineer – Manufacturing to drive quality systems, compliance and process validation for a medical device manufacturing site.

The role offers an on-site, full-time position with a salary range of $80,000 to $100,000 per year and a competitive benefits package including medical, dental, vision, life and disability insurance, 401K, paid time off and holidays.

Qualifications

• Bachelor's degree in science, engineering or equivalent required.
• 3-7 years of relevant experience in medical device manufacturing preferred.
• Strong knowledge of ISO 13485 and FDA Part 820 quality systems.

Responsibilities

• Lead in supporting compliance for medical device manufacturer throughout the supply chain.
• Perform risk assessments and participate in CAPA, PFMEA, IQ/OQ/PQ/PPQ validation.
• Develop/inspect procedures for product and equipment quality checks.
• Support process controls, packaging/labeling, and production controls.
• Coordinate internal and external audits and supplier audits as needed.
• Drive continuous improvement and quality system updates.

Skills

Quality systems

Regulatory compliance

Statistical analysis

Process validation

CAPA

Education

Bachelor's degree in science or engineering

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Engineer - Manufacturing

Full-Time Quality Assurance St Charles, IL, US

Salary Range: $80,000.00 To $100,000.00 Annually

About AJR Enterprises:

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.