Quality Engineer

Exalta Group • Bonita Springs, FL

32d • Onsite

About The Position

This role reports directly to the Quality Manager and works closely with the Engineering and Operations departments to ensure seamless compliance and product quality.

Requirements

• Bachelor's degree in Engineering or related technical discipline. Experience may be considered in lieu of education for exceptional candidates
• 3–5 years of Quality experience in medical device manufacturing.
• Experience with FDA 21 CFR Part 820/QMSR and ISO 13485.
• Strong knowledge of CAPA, root cause analysis, process validation, SPC, and risk management.
• Experience in a contract manufacturing (CMO/CDMO) environment preferred.

Nice To Haves

• ASQ Certified Quality Engineer (CQE)
• Six Sigma Green Belt or Black Belt

Responsibilities

• Participate in and support external regulatory, customer, and notified body audits (including FDA, BSI, or similar registrar audits)
• Lead investigations using Root Cause Analysis (RCCA) and 8D Problem Solving to issue and manage Nonconformance Reports (NCR), Corrective Action Requests (CAR), and Corrective & Preventive Action (CAPA).
• Manage Supplier Quality Management and Quality Management Systems (QMS), including Supplier Assessments, supplier performance improvement, source inspection, and product acceptance.
• Analyze quality metrics, identify trends, and drive continuous improvement initiatives.
• Collaborate on Cross-Functional Projects to improve product quality, process capability, and manufacturing performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level