Senior Quality Controller

2 weeks ago

Loni, Uttar Pradesh, India Assurer Auto Parts Full time ₹ 3,84,000 - ₹ 4,80,000 per year

GALAXY INNOVATIONS is medical device(orthopaedic implants and instruments) manufacturing company looking for Senior Quality Engineer

Key Responsibilities – Senior Quality Engineer

  • Ensure Quality Compliance
  • Maintain compliance with industry standards (e.g., ISO 9001, ISO 13485, IATF
  • Lead internal and external audits, including regulatory inspections.
  • Lead CAPA and Root Cause Analysis
  • Investigate quality issues using tools like 5 Whys, Fishbone, and 8D.
  • Drive effective corrective and preventive actions (CAPA).
  • Oversee Process & Product Validation
  • Lead IQ/OQ/PQ activities and process validations.
  • Ensure consistent product performance and regulatory compliance.
  • Manage Supplier Quality
  • Evaluate, audit, and monitor supplier performance.
  • Address supplier non-conformances and drive continuous improvement.
  • Support Risk Management
  • Conduct and update PFMEA/DFMEA.
  • Identify and mitigate product and process risks proactively.
  • Drive Continuous Improvement
  • Lead quality improvement projects using Lean, Six Sigma, or Kaizen.
  • Analyse data to reduce defects and improve process capability.
  • Change Management
  • Assess quality impact of engineering or process changes.
  • Ensure proper documentation and traceability.
  • Mentor and Train Team Members
  • Provide guidance to junior engineers and quality inspectors.
  • Conduct training on quality systems, tools, and procedures.
  • Customer Complaint Handling
  • Investigate field issues and customer feedback.
  • Coordinate cross-functional teams to resolve customer concerns.
  • Quality Reporting & Metrics
  • Monitor and report key quality KPIs (e.g., yield, defect rate, audit findings).
  • Present findings and recommendations to leadership.

HIGHLY PREFRENCE CANDIDTES FROM MEDICAL INDUSTRY , AUTOMOBILES INDUSTRY & AEROSPACE INDUSTRY

Job Types: Full-time, Permanent

Pay: ₹15, ₹40,000.00 per month

Benefits:

  • Paid sick time

Work Location: In person

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