Director Quality Systems
4 weeks ago
Primary Function of Position
The Director, Quality Systems will be a key member of the Quality Systems and Compliance leadership team with broad responsibilities. The successful candidate will help to create a quality management infrastructure that is compliant, effective, efficient and agile and that supports a rapidly growing international business model with complex and diverse product lines. S/he will provide quality management oversight for elements of the Intuitive Surgical Quality Management System (QMS), which includes design controls, corrective and preventive action, training, document controls, production and process controls, facilities and equipment controls, and material controls through to GMP for all aspects including identification and escalation of quality system and product issues. Provide strategic guidance regarding the establishment and monitoring of quality metrics for executive review to determine health of QMS and lead the team in continuous improvement and planning for growth activities as needed. S/he will grow, develop and manage team to interface and support all regulatory compliance requirements of the company.
Essential Job Duties
- Establish programs, guidelines and procedures related to areas of responsibility to include but not limited to Quality systems including Change Control, Data and Document Management and Records Management and Compliance Training
- Working with Learning Management staff to develop and deploy an optimized compliance training program and monitoring.
- Working with cross functional leadership to implement best practices for change control documents and records management.
- Working with Heads of RAQA APAC and RAQA EMEA to ensure international quality systems are compliant and effective for local, regional and corporate business needs as well as regional regulatory requirements.
- Responsible for assisting in management of regulatory inspections/external audits and related compliance activities. Support internal audits execution and related findings.
- Working with Head of Audit, help define programs that ensure the verification and monitoring of the effectiveness of the quality system and its compliance to applicable regulations and standards.
- Working with Head of RAQA Operational Excellence, help define the Quality Systems improvement strategy that includes responsibilities for development, implementation and the continuous improvement of ISI quality system(s).
- Provide training and consulting to internal customers on quality system regulatory compliance.
- Partner across the company to drive standardization of Quality Systems.
- Establish programs to effectively monitor and assess the global quality system through key performance indicators, metrics and scorecards.
- Work to ensure the timely identification, escalation and corrective actions resulting from Management Review and Quality System reviews.
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