Description
Major Responsibilities & Duties:
Business Improvements
. Support quality improvement initiatives such as process and product characterizations that lead to continuous/cost improvements.
. Review/analyze 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 skill sets for new product introductions, and product life cycle management.
Compliance/Regulatory
. Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
. Champions compliance to applicable Global Regulations and standards (eg QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
. Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.