Executive Quality Engineering

Johnson & Johnson

Aurangabad, Maharashtra, India
Iso 13485 regulatory compliance
Design verification and validation
Risk management iso 14971
The role ensures product quality and regulatory compliance for manufacturing operations in the healthcare sector

Job Summary

  • The role ensures product quality and regulatory compliance for manufacturing operations in the healthcare sector.
  • Responsibilities include managing risk activities per ISO 14971, executing design validations, and leading root cause analyses for non-conformities.
  • Candidates will partner with R&D to apply design controls and ensure customer critical-to-quality requirements are met through robust control plans.

Matching Summary

The role ensures product quality and regulatory compliance for manufacturing operations in the healthcare sector.

Skills & Requirements

Must-have

  • ISO 13485 regulatory compliance
  • Design verification and validation
  • Risk management ISO 14971
  • GxP procedure creation
  • Root cause analysis
  • Statistical data analysis

Nice-to-have

  • Lean principles application
  • Process excellence methodology
  • Cross-functional collaboration
  • Continuous improvement mindset
  • ERP/PLM system proficiency

Key Requirements

  • Experience with medical device regulations
  • Knowledge of ISO 13485 standards
  • Proficiency in GxP documentation
  • Background in statistical analysis
  • Familiarity with IQ/OQ/PQ validation

Work Rights

Not specified

Tailored Resume

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