Quality Analyst - LIMS

Fusion Life Sciences Technologies (www.fusionlifesolutions.com ) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive. We proudly partner with 120+ clients such as Johnson & Johnson, Haemonetics, Delta, Caterpillar, Artisan Chef, Baxter, and many more. Our wide network of consultants and contract-to-hire engineers brings deep expertise across Engineering, Technical, Administrative, Healthcare, Life Sciences, Blue Collar, Skilled Trades, IT, Software Development, Manufacturing, and Supply Chain sectors. What sets us apart is our AI-powered, in-house software's enabling us to source and screen top talent within hours. This ensures rapid response times, high-quality matches, and virtually zero attrition.

Job Title: Quality Analyst 

Location:  Raynham, MA

Duration : 12 Months

Not open C2C only W2 - Onsite role.

Job Summary

This role supports the Quality Assurance organization by maintaining and improving quality systems and product performance through effective use of LIMS (Labware/LabVantage), inspection plans, and compliance processes. The position ensures inspection data integrity, supports regulatory compliance, and drives continuous improvement across product lifecycle, manufacturing, and quality operations.

Key Responsibilities

• Quality Systems & LIMS
• Administer and support Labware v7 and LabVantage v8.8 LIMS platforms, including master data setup and inspection plan migration.
• Provide day-to-day LIMS user support, troubleshooting, reporting, and training.
• Support LIMS change control and system improvements in collaboration with IT and Quality.

Compliance & Audits

• Ensure compliance with QSR, ISO 13485, GMP, and Client standards.
• Support internal/external audits and conduct line/area audits for production controls and CAPA effectiveness.

Product Quality & NCMR

• Support Material Review Board (MRB) activities and non-conformance investigations.
• Drive defect classification, material segregation, and quality metrics tracking.

Process & Product Validation

• Draft, execute, and support IQ/OQ/PQ, TMV, and software validation activities.
• Support design transfer and new product introductions through risk management and inspection planning.

 Data & Continuous Improvement

• Perform data analysis, sampling plans, MSA, and statistical evaluations to support process improvements.
• Partner with Supply Chain, Manufacturing, and Suppliers on process controls and risk mitigation.

Qualifications Snapshot

• Bachelor’s Degree (0–2 years’ experience)
• LIMS: Labware v7 & LabVantage v8.8 (basic–intermediate)
• Strong Excel / data analysis skills
• Knowledge of GD&T, inspection methods, GMP/ISO/QSR
• Hands-on, analytical, and problem-solving mindset.

All your information will be kept confidential according to EEO guidelines.