Senior Quality Engineer — Lead Quality & Compliance

PAXXUS; Addison (IL); On-site; USD 113,000 - 138,000; Full time

Benefits offered by this job

401(k)

401(k) matching

Employee assistance program

Health insurance

Health savings account

Life insurance

Paid time off

Referral program

Vision insurance

Job summary

PAXXUS, a family-owned healthcare packaging company in Addison, IL, seeks a Senior Quality Engineer to oversee the Quality Management System and drive continuous improvement. You will report to the Director of QA & RA and ensure quality system compliance to deliver high-quality products.

You will lead investigations into quality issues, coordinate validations (IQ/OQ/PQ), and support ISO audits. Strong customer and supplier communication and adherence to GMP are essential for success.

Qualifications

• 5+ years of experience in Quality Engineering in high-volume manufacturing; packaging strongly preferred.
• 3+ years’ experience delivering outward communication directly to customers and suppliers
• 3+ years' experience investigating and responding to customer complaints
• Strong experience coordinating validation activities including IQ, OQ, and PQ
• B.S. Degree in an engineering or technical discipline that includes training in statistical techniques and problem-solving tools
• Audit experience in ISO 9001, ISO 13485, or equivalent QM standard
• Strong verbal/written English communication skills and ability to work with a diverse team

Responsibilities

• Lead investigations into quality issues and deliver responses to customer complaints
• Proactively provide effective communication to customers, suppliers, and upper management on all owned tasks
• Coordinate validation activities, including operational, and performance qualifications
• Monitor, record, analyze, and report on internal quality metrics
• Participate in customer, internal, and supplier audits based on ISO 9001 and ISO 13485 standards
• Assist in providing ongoing training on our Quality Management System and Good Manufacturing Practices (GMP) across our organization

Skills

Quality Engineering

Customer communication

IQ/OQ/PQ

Validation coordination

Statistical techniques

Education

Bachelor's degree in engineering or technical discipline

Tools

ISO 9001

ISO 13485

Job description

PAXXUS, a family-owned healthcare packaging company in Addison, IL, seeks a Senior Quality Engineer to oversee the Quality Management System and drive continuous improvement. You will report to the Director of QA & RA and ensure quality system compliance to deliver high-quality products.

You will lead investigations into quality issues, coordinate validations (IQ/OQ/PQ), and support ISO audits. Strong customer and supplier communication and adherence to GMP are essential for success.