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New Product/Process Introduction:
- Partners with R&D and other cross-functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
- Supports new product introduction as part of design transfer.
- Support the complete process verification activities and should have a completed understanding of Validation documents.
- Support on the Equipment IQ, OQ & PQ.
- Support the new test method development and validation.
Business Improvements:
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Conduct benchmarking to develop more effective methods for improving quality
- Supports the development of quality engineering and quality compliance with the right skillsets for new product introductions, and product life cycle management.
Compliance/Regulatory:
- Analyse whether current products and processes (including actions or decisions conducted) comply with standards such as the QSRs, ISO 13485, etc.
Product Quality, Control & Disposition and Performance Standards
- Analyze/review the effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.
