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Quality Engineer

Katalyst Healthcares and Life Sciences

Job Summary:
We are seeking an Quality Complaint Investigation to support complaint investigations, quality system activities, and continuous improvement initiatives within a regulated medical device manufacturing environment. The role involves analyzing quality data, conducting root cause investigations, supporting CAPA activities, and ensuring compliance with FDA and GMP standards

Responsibilities:

  • Review customer complaints and associated service data to determine risk levels and identify problem/cause codes.
  • Conduct complaint investigations and perform detailed root cause analysis.
  • nalyze data from quality systems including Complaints, Field Corrective Actions (FCA), FDA MDRs, and other quality inputs to identify trends and systemic issues.
  • Prepare investigation summaries, reports, and recommendations based on analysis.
  • Review existing investigation reports and identify GMP compliance gaps.
  • Support development and implementation of corrective and preventive actions (CAPA).
  • Drive continuous improvement initiatives and process control activities.
  • Conduct data analysis using statistical and quality tools.
  • Support maintenance activities for existing product lines and quality systems.
  • Collaborate cross-functionally to improve product quality and compliance standards.
Requirements:
  • Bachelor's Degree in Engineering (B.E./B.Tech or equivalent).
  • 1-3 years of experience in the Medical Device industry.
  • Knowledge of FDA Quality System Regulations (21 CFR 820) and cGMP requirements.
  • Experience in complaint handling, investigations, and root cause analysis.
  • Familiarity with CAPA processes and quality systems.
  • Strong analytical and problem-solving skills.
  • Experience with statistical tools/software such as Minitab is a plus.
  • bility to read and interpret technical drawings and engineering documentation.
  • Proficiency in MS Office tools (Excel, Word, PowerPoint) and databases.
  • bility to manage multiple tasks and projects effectively.
Preferred Experience:
  • Experience with ANSI/ISO/ASQC standards.
  • Exposure to continuous improvement methodologies and process controls.
  • Knowledge of medical device regulatory environments and compliance practices
Work Environment:
  • FDA-regulated manufacturing environment.
  • Temperature and humidity-controlled workspace.
  • May require use of static-protective equipment while in designated work areas.
Physical Requirements:
  • bility to sit for extended periods.
  • Good hand-eye coordination and dexterity.
  • bility to lift up to 40 lbs when required.
Vacancy posted 2 days ago
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