Principle Quality Assurance Process Specialist

• Leadership of the end-to-end QMS change control process, providing subject matter expertise to all sites and global functions
• Drive the standardisation & best practise of the QMS change control process across all sites and functions, covering all aspects of the product life cycle management and compliance
• Ownership and accountability for key global change controls concerning the QMS or major quality related changes. To include leadership of the Global Cross Functional Review Team
• Working with the DBS tools, to improve effectiveness and efficiency of other key quality processes as required, in line with the customer expectations
• Ownership of the KPI replated to Change Controls, specific to on time completion and effectiveness check. Prepare reports on KPI, identify trends and improvement opportunities

• Bachelor's Degree, or equivalent experience in regulated medical device, pharmaceutical or life sciences industry
• Quality Assurance/ Quality Engineering experience in a GMP environment
• Demonstrated good collaboration skills and expertise to effectively communicate the organization
• Understanding QMS and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485 and ISO 9001
• Exceptional analytical, problem solving & root-cause analysis skills as well as proven track record working cross – functionally and at global level

Comprehensive understanding of electronic systems, Magic and Veeva, used to manage change control processes.