What are the responsibilities and job description for the Quality Engineer position at Fusion Life Sciences Technologies LLC?
1. Quality Engineer (Validation) – Raynham, MA
- Requires 5 years of experience in the medical device industry within a GMP-regulated environment
- Lead and execute equipment and process validation (IQ/OQ/PQ) activities
- Develop and review validation protocols, reports, and Traceability Matrices (TMVs)
- Perform risk assessments (FMEA) to support validation strategy and compliance
- Support manufacturing site build/expansion, including commissioning and qualification
- Ensure compliance with cGMP, FDA (21 CFR 820), and ISO 13485 standards
- Collaborate with cross-functional teams (Engineering, QA, Manufacturing)
- Drive process validation lifecycle (PPQ, CPV) activities
- Support deviations, change control, and CAPA related to validation
2. Quality Engineer – Palm Beach Gardens, FL
- Requires 5 years of experience in the medical device industry with strong QMS exposure
- Manage CAPA, NCRs, and deviation investigations ensuring regulatory compliance
- Support global service and repair quality operations with issue resolution and trending
- Lead and support product transfer projects across sites
- Work with cross-functional global teams (EMEA/APAC) for quality improvements
- Perform root cause analysis and implement effective CAPA
- Monitor and improve quality KPIs and metrics
- Ensure compliance with QMS, FDA (21 CFR 820), and ISO 13485
- Drive continuous improvement initiatives across global operations