Senior Quality Controller

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 16949).
• 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: ₹15,998.61 - ₹40,000.00 per month

Benefits:

• Paid sick time

Work Location: In person