Quality Analyst - LIMS

TechtrueupRaynham, MA
3hOnsite

About The Position

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.

Requirements

  • 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.

Responsibilities

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