Quality Engineer

EXALTA Group's; Town of Florida (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

EXALTA Group's in New York seeks an experienced Quality Engineer to ensure product quality and regulatory compliance within a fast‑paced medical device manufacturing environment. You will collaborate with Engineering and Operations, report to the Quality Manager, and lead quality improvement initiatives.

You will participate in audits (FDA, ISO 13485), manage NCRs and CAPA, oversee supplier quality, analyze metrics, and drive continuous improvement across processes.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 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 and support external regulatory, customer, and notified body audits (FDA/BSI/reg registrar).
• Lead investigations using RCCA and 8D to issue NCR, CAR, and CAPA.
• Manage Supplier Quality Management and QMS activities, including supplier assessments.
• Analyze quality metrics, identify trends, and drive continuous improvement.
• Collaborate on cross-functional projects to improve product quality and manufacturing performance.

Skills

CAPA

Root Cause Analysis

Process Validation

SPC

Risk Management

Quality Systems

Education

Bachelor's degree in Engineering or related

Job description

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

Key Competencies

• Analytical problem-solving
• Attention to detail
• Strong communication and collaboration
• Customer focus
• Continuous improvement mindset
• Ability to manage multiple priorities in a fast-paced manufacturing environment