Quality Systems Director
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:
Apply Now
Apply Now
• 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:
Apply Now
Apply Now