Quality Engineer

United States·Bonita SpringsRegular Full-Timemid

EngineeringQuality Engineer

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Quick Summary

Key Responsibilities

Participate in and support external regulatory, customer, and notified body audits (including FDA, BSI,

Technical Tools

EngineeringQuality Engineer

Position Summary:

Reports directly to the Quality Manager, while working in close partnership with the Engineering and Operations departments to ensure seamless compliance and product quality.

Key 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.

Requirements

~1 min read

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.