TekniPlex

Lead the design and deployment of enterprise Quality systems ensuring compliance and fostering a quality-focused culture. | Requires 10+ years in industry leading Quality Management processes, with strong regulatory knowledge and leadership skills. | Job Description: • Lead the design and development of the enterprise Quality system, ensuring alignment with Regulatory requirements and customer needs. • Establish and lead cross functional teams across the business to achieve appropriate collaboration and SME input required for the successful development of the Quality system. • Leveraging EQMS capabilities, design and implement functions workflows that facilitate user adoption and support compliance. • Develop and execute a comprehensive strategy that will ensure the effective deployment of the Quality processes across the business, with emphasis on creation of training material and the provision of training. • Support, coach and assist the manufacturing organization to facilitate the adoption of the Quality system post deployment. • Establish governance structures for overall delivery of the QMS program, provide timely updates to the Leadership team and sites management regarding planning and execution. • Establish Key Performance Indicators (KPI’s) to ensure the overall effectiveness of the Quality System is monitored and continuous improvements are identified. • Promote the Quality culture required within the business to aid compliance with international standards and deepen the understanding of Medical Device and Pharmaceutical customer needs. Requirements: • Bachelor’s degree with at least 10 years industry experience leading Quality Management system and proven ability in the development of Quality processes. • Strong understanding of regulated industry, specifically ISO 13485, ISO 14971 and FDA 21 CFR 820. • Effective communication and report writing skills. • Strong negotiation skills with customer-oriented attitude. • Excellent analytical ability to grasp the key points from complicated details. • Good leadership capabilities to lead project to successful completion. • Familiarity with tools, concepts and methodologies of quality management. • Ability to travel approximately 10-20% (including international travel). Benefits: