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Director Or Senior Director, Quality
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$200,000
- Ensures compliance with applicable standards including ISO certification, FDA and relevant foreign country regulations along with customer requirements across the design, manufacture, provision and support of the Company's products.
- Develops, communicates and administer an efficient and effective risk based and phase appropriate Quality Management System (QMS) in compliance with the global regulatory requirements and industry-recognized best practices for life science suppliers.
- Ensures that the QMS demonstrates regulatory compliance with applicable regulations and maintains on-going certification to all relevant regulatory bodies.
- Manages, develops and/or oversees the Quality team's responses to all QMS issues to timely close including; non-conformances, performance of Risk Assessments, CAPA investigation and support, design validation, QMS improvements and enhancements, NCR's, compliance with regulations, policies, procedures, external and internal audits, Technical support issues, etc.
- Enforces all relevant health, safety, and environmental policies (i.e., EHS, OSHA) in their span of control to ensure compliance and promote a safe working environment.
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