Job Description
**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.