Quality Engineer

Exalta Group; Hunters Ridge (FL); On-site; USD 75,000 - 110,000; Full time

Job summary

Exalta Group in Bonita Springs, FL, is seeking a Quality Engineer to ensure product quality and regulatory compliance across engineering and operations. You will report to the Quality Manager and drive CAPA investigations, NCR/CAR management, and QMS activities with supplier oversight.

The ideal candidate has 3–5 years in medical device quality, hands-on RCA/8D, and experience with FDA 21 CFR Part 820/QMSR and ISO 13485. CM0/CDMO exposure is a plus.

Qualifications

• Bachelor's degree or exceptional candidates may substitute education
• 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

Responsibilities

• Participate in external regulatory and customer audits (FDA, BSI, and similar)
• Lead RCCA and 8D investigations; manage NCRs, CARs, CAPA
• Manage Supplier Quality Management and QMS activities including supplier assessments
• Analyze quality metrics; identify trends; drive continuous improvement initiatives
• Collaborate on cross-functional projects to improve quality and manufacturing performance

Skills

Root Cause Analysis

CAPA

Process Validation

SPC

Risk Management

Education

Bachelor's degree in Engineering or related field

Job description

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Quality Engineer

Regular Full-Time Indirect Bonita Springs, FL, US

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.

Qualifications

• 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.

Preferred Certifications

• ASQ Certified Quality Engineer (CQE)
• Six Sigma Green Belt or Black Belt
• Analytical problem-solving
• Strong communication and collaboration
• Ability to manage multiple priorities in a fast-paced manufacturing environment