Quality Engineer - Manufacturing

Ufp-Technologies; Saint Charles (MO); On-site; USD 80,000 - 100,000; 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 - Manufacturing to join our St. Charles, IL site. You will ensure quality engineering needs are met across operations, with focus on compliance, process validation, CAPA and vendor quality.

Responsibilities include risk analysis, IQ/OQ/PQ/PPQ validation, supplier audits, and collaboration with operations, supply chain and NPD teams to drive continuous improvement in a medical-device manufacturing environment.

Qualifications

• Bachelor's degree in science, engineering or equivalent.
• 3-7 years 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)
• Experience conducting supplier audits and writing supplier contracts
• Familiarity with statistical analysis

Responsibilities

• Support compliance for medical device manufacturing in ID/traceability across the supply chain.
• Manage acceptance activities, non-conforming material and packaging/labeling controls.
• Lead production/process controls and process validation (IQ/OQ/PQ/PPQ).
• Coordinate CAPA, risk assessments, audits and corrective actions.
• Collaborate with operations, supply chain and NPD teams.

Skills

Quality systems

Regulations

Statistical analysis

CAPA

Process validation

Risk assessment

Education

Bachelor's degree in science, engineering or equivalent

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

2 days ago Requisition ID: 1692

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.