Demo

Quality Engineer

Katalyst Healthcares and Life Sciences
Putnam, CT Full Time
POSTED ON 4/26/2025
AVAILABLE BEFORE 5/19/2025

Responsibilities :

  • Provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards.
  • May be responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development.
  • May manage the process and produce non-conformances in line with company procedures.
  • May conduct quality assurance tests to ensure product specifications are met. May review, investigate, resolve and report on quality discrepancies. May develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards.
  • May monitor, investigate, and report on customer complaints. May obtain the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development.
  • May lead to audit and inspection preparation, resolution of audit and inspection findings. May have frequent interaction with other functional areas and operating entities.
  • Our Quality Engineer assures the quality of processes and products by performing audits, inspections, tests, defect analysis, trend analysis, programming & troubleshooting inspection equipment, calibration maintenance, and reporting on results of measurement standards.
  • Assures consistent quality of suppliers and production by validating processes; providing documentation from measurement analysis, and helping departments understand the interpretation of collected data.

Requirements :

  • Work with the manufacturing plants and Corporate EHS & Legal Team to provide declarations or responses to customers on regulatory compliance issues, such as EICC, RoHS, REACH & EPA.
  • Bachelor's degree Required; Engineering preferred.
  • 5 years' experience in a Quality, Process, or Manufacturing Engineering role.
  • Knowledge of SPC with validating control charts and interpreting results and make recommendations to improve.
  • Working knowledge in statistical tools (such as SPC, MSA, Pareto, ANOVA etc.) and quality tools (such as FMEA, Cause and Effect Diagram, 8D etc.).
  • Proficient in software such as PowerPoint, Excel, Minitab, etc.
  • Lead and coordinate customer quality complaint resolution with the manufacturing plant for root cause investigation.
  • Review CAPA from the manufacturing plant to determine the robustness. Work with the manufacturing plant to define customer acceptable CAPA.
  • Review 8D from the manufacturing plant. Customize the customer version of 8D (in local language if needed) report.
  • Work with the individual manufacturing plant to implement QMS improvement requests from customers.
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