Quality Systems Director

🌍 Remote, USA 🎯 Full-time 🕐 Posted Recently

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.

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:

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