The Director, Quality Systems will be a key member of the Quality Systems and Compliance leadership team with broad responsibilities. The successful candidate will create a quality management system/infrastructure that is compliant, effective, efficient and agile that supports a rapidly growing international business model with complex and diverse product lines. S/he will provide quality management oversight for all 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 team in continuous improvement or planning for growth activities as needed. Oversee and manage facility inspections and audits required by government / regulatory agencies on a global basis.
Grow, develop and manage team to interface and support all regulatory compliance requirements of the company. Roles and Responsibilities:
- Provide leadership and act as primary liaison to drive simplification and integration of quality system requirements and business processes to ensure compliance and facilitate global business growth - Responsible for establishing and maintaining the global compliance program to ensure compliance with global regulatory requirements, international standards, company policies and procedures. - Establish and maintain programs that ensure the verification and monitoring of the effectiveness of the quality system and its compliance to applicable regulations and standards. - Provide oversight to establish compliant Quality Management System (QMS) (includes but not limited to programs, guidelines and procedures related to all areas of the QMS such as Management Review, CAPA, Non-conformances, Quality Systems Review, Quality Planning, Quality Objectives, Analytics and Quality Scorecard, Change Control, Data and Document Management, Compute System Validations, Records Management and Training Management. - Establish and oversee the Quality Systems improvement strategy that includes responsibilities for development, implementation and the continuous improvement of the ISI quality system that is agile and scalable. - Act as SME and provide training/consultation to internal customers on applicable regulatory requirements (proactively and reactively) - Establish guidelines and procedures for ISI Learning Management System to develop and deploy general QS training. - Provide Analysis of quality data to support Regulatory Compliance activities including quarterly Quality Review Board Meetings, responses to agency requests for information and analyses to support quality improvement projects. - Partner across the company to drive standardization of Quality Systems. Establish the Quality Planning and Quality Objectives process ensuring an effective monitoring and escalation process. Establish programs to effectively monitor and assess the global quality system through metrics and scorecards. - Facilitate data input into the Management Review process that assures linkage of all ISI sites and provides reviews and visibility to Senior Management. Ensure timely identification and escalation of emerging issues resulting from Management Review and Quality System review. - Responsible for management of regulatory inspections (internal and external) and related compliance activities.
- A minimum of a Bachelor’s Degree is required. An Engineering, Science, Mechanical or Electrical Engineering degree is preferred.
- A minimum of 10 years’ experience in a Medical device setting, with a minimum of 5 years in role with responsibility for quality and compliance OR a Masters’ degree and a minimum of 6 years’ experience in a Medical device setting Demonstrated leadership to ensure alignment of priorities and program delivery is required - Demonstrated strong interpersonal skills and a passion for developing teams and people to their highest potential is required - Demonstrated ability to lead through influence and expertly communicate program updates in both oral and written formats in a cross functional matrix organization is required - Demonstrated experience in lean/six sigma tools to lead and drive process improvements, efficiency and effective customer satisfaction (both internal and external) to ensure growth and scalability is required - Working knowledge/experience of risk management practices, Corrective and Preventative Actions and regulatory requirements such as FDA QSR’s, ISO 13485, Annex II of the European Medical Device Directive, CMDR, MHLW Ordinances, Korea GMP Regulations, TGA and external regulatory body’s audits is requiredWorking knowledge of project management tools and techniques is desirable - RAC certification, ASQ - CQA, CQE or SCQE, and/or ISO Lead Assessor is desirable
We are an AA/EEO/Veterans/Disabled employer.
Additional Salary Information: Competitive Director Level Compensation in the Bay Area with an outstanding equity package
Joining Intuitive Surgical means becoming part of an organization that strives to make surgery more effective, less invasive and easier on surgeons, patients and their families.
The idea of surgical robotics was little more than a curiosity until 1999, the year Intuitive Surgical introduced the da Vinci® Surgical System. Today, Intuitive Surgical is the global leader in the rapidly emerging fie...ld of robotic-assisted minimally invasive surgery.
With its corporate headquarters located in Sunnyvale, California, Intuitive Surgical serves customers throughout the United States and internationally, providing technology innovation across cardiac, thoracic, urology, gynecologic, colorectal, pediatric and general surgical disciplines.