We are seeking a Quality Engineer to support manufacturing quality operations in a regulated medical device environment. This role is responsible for ensuring product quality, supporting production activities, and maintaining compliance with ISO 13485 and FDA requirements.

The Quality Engineer will play a key role in driving product quality, supporting manufacturing and process transfers, and strengthening the Quality Management System (QMS) through hands-on floor support and structured problem solving.

Key Responsibilities

Production Quality Support

Support in-process inspection, final release, and lot history record review
Lead MRB activities and disposition of nonconforming material
Support supplier and customer quality issue resolution
Monitor supplier quality performance and corrective actions
Review complaints and returned product investigations

Quality Systems & Compliance

Support ISO 13485 and FDA 21 CFR Part 820 compliance
Participate in internal and external audits and audit readiness activities
Lead or support CAPA investigations and root cause analysis
Support risk management activities (PFMEA, control plans)
Support change control and documentation updates

Process & Facility Transfer Support

Support quality oversight of process and facility transfers
Partner with engineering and operations on validations and requalification activities (IQ/OQ/PQ)
Update inspection methods, control plans, and quality documentation during transfers
Ensure process controls, SPC, and quality metrics are implemented and maintained

Continuous Improvement

Analyze quality trends and support data-driven improvements
Improve inspection methods, sampling plans, and process controls
Support cross-functional problem solving and operational improvements

Qualifications

5+ years of quality engineering experience in medical device or regulated manufacturing
Strong knowledge of ISO 13485 and FDA 21 CFR Part 820
Experience with CAPA, root cause analysis, and audit support
Experience supporting manufacturing operations and production floor quality issues
Familiarity with SPC, MSA, and statistical tools (Minitab preferred)
Experience supporting product or process transfers strongly preferred
ASQ certification (CQE/CQA) preferred

Must be eligible to work in the United States without restriction and without the need for current or future sponsorship.

Resumes can be confidentially sent to eli.stader@gogpac.com or call direct at (319)774-8916.