
Senior Quality Controller
2 weeks ago
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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