Silk Road Medical, based in Sunnyvale, CA, is seeking a Head, Quality Management who will provide strategic direction, development and implementation of the Silk Road Medical Quality System spanning product concept through market surveillance. The incumbent will ensure that the Quality Policy is understood, implemented and maintained at all levels of the organization and ensure that the quality system is suitable and effective to satisfy regulatory requirements, industry trends and the company’s quality objectives. This individual also leads the development, alignment, and deployment of new processes to comply with major emerging and international regulatory initiatives and for continuous improvements.
- Maintain the Quality Management System with a focus on scaling for organizational growth
- Implement and manage eQMS
- Provide leadership and guidance to the Quality team. Ensure adequate and trained resources by recruiting, training, developing team members. Assist in development and administration of department budgets and schedules.
- Provide leadership for and oversee the following Quality functions:
- Management Review
- Corrective and preventive actions
- Document control and records
- Internal and external quality audits
- Nonconforming materials
- Product feedback and complaints/MDR and Vigilance reporting
- Personnel training
- Inspection and quality control
- External standards maintenance and gap analyses
- Engage the cross functional organization in developing policies and creating processes to comply with cGMP and CFR requirements/guidance
- Interface with FDA, CA State Department of Health and Notified Bodies during company inspections and audits
- Actively collaborate with the Heads of Operations and Research and Development.
- Actively collaborate with Research and Development team on design control activities and provide project support
- Actively collaborate with Operations on (1) scaling of production to meet demand and (2) supplier selection, maintenance and auditing
Minimum Qualifications, Experience & Skills Required
- Minimum of ten years of related experience in the medical device industry in addition to a minimum of five years of supervisory experience
- Extensive knowledge of ISO 13485 and FDA 21 CFR 820 requirements for the design and manufacture of medical devices
- Experience at all phases of product development, including commercialization and scaling for aggressive commercial ramp.
- Experience in leading external regulatory audits and inspections
- Experience leading a Quality Management team
- Experience with Chinese/Japanese quality system/inspection requirements highly desirable
- Experience with other OUS quality system/inspection requirements preferred but not required (Australia, Brazil, South Korea, etc.)
- Excellent oral and written communication skills
- Excellent interpersonal and team building skills
- Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solving
- Ability to exercise creativity and judgment
- Excellent communications and time management skills required
Interested candidates should submit their resume to email@example.com.