Quality Assurance Engineer

Job Summary

We’re looking for a Quality Assurance Engineer with strong experience in plastic injection molding to support a growing medical device manufacturing operation. If you thrive in ISO-regulated environments and enjoy owning quality processes from investigation through validation, this could be a great fit.

Key Responsibilities

• Support and sustain an ISO 13485–compliant QMS
• Lead nonconformance investigations, CAPAs & root cause analysis
• Drive IQ/OQ/PQ validations for injection molding processes
• Partner with Manufacturing & Engineering to optimize process capability
• Review/approve ECOs, control plans & inspection methods
• Support FMEAs and risk management activities
• Assist with supplier quality audits & corrective actions
• Ensure DHRs, DMRs & quality documentation remain audit-ready
• Translate customer requirements into practical quality solutions
• Train teams on quality standards and inspection methods

Qualifications

• Bachelor’s degree in Engineering, Quality, Materials Science, or related field
• 3+ years in medical device manufacturing
• Direct plastic injection molding experience
• Hands-on knowledge of ISO 13485 & FDA QSR
• Strong background in metrology, GD&T & SPC
• Proven ability to lead investigations and create compliant documentation

Preferred

• Class II or III medical device experience
• CQE, CQA, or Six Sigma certifications
• Cleanroom or automated inspection experience
• ERP/QMS system familiarity

Why Join Us

• Competitive salary + strong benefits
• High ownership within a plastics-focused quality environment
• Opportunity to make a real impact in a regulated, life-saving industry
• Collaborative culture driven by continuous improvement