Quality Assurance Specialist - San Jose California

Quality Assurance Specialist - San Jose California

Quality Assurance Specialist

Location:  San Jose, California

We have an exciting opportunity for a full time Quality Assurance Specialist to join our growing team located in San Jose, California.  The Quality Assurance Specialist is responsible for day-to-day support of various aspects of the Quality Management System, including document control, materials review board (MRB) receiving inspection, in-process, final inspection, non-conforming materials program, calibration program, batch record/device history records reviews, training records, quality record management, etc., providing an opportunity to apply textbook knowledge with practical experience. This position will report to the Senior Manager, Quality.

What you will do:

  • Assist and ensure the Quality Management System and regulatory compliance requirements are effectively maintained, implemented and monitored.
  • Maintain Document Control system
  • Manage and maintain Internal Training program
  • Monitors Quality issues, identifies actions needed to correct, highlights issues to management and drives corrections.
  • Maintains and controls the documentation system. Experience in Agile and/or Arena PLM preferred.
  • Provide support for both internal and external audit activities as necessary.
  • Manage Approved Supplier List, Employee Training, and External Standards.

       Interfaces with R&D and Operations and other area Managers to implement process improvements.

  • Investigates and performs failure analysis on customer complaints.

       Monitors compliance with standard operating procedures and ISO/QSR requirements.

  • Provide continuous assessment of the Quality Management System including CAPA, internal audit and other related processes to ensure compliance requirements.
  • Identify gaps, enhancements and create/establish process checklists/forms, work instructions, non-conformance reports and ensure all quality check procedures are put in place.
  • Assist with corrective actions, process investigations and implementation activities.

What you will need:

  • High School Diploma or related technical area, or 2-5 years of Quality Systems experience.
  • Experience managing Document Control Systems
  • Knowledge of ISO 13485, FDA QSR requirements required
  • Complaint Handling/MDR (preferred)
  • Corrective and Preventive Actions (CAPA)
  • Certified Internal Auditor (preferred)
  • Must have ability to process, analyze and present data
  • Excellent oral and written communication skills required

What you’ll be part of – our Venus Concept Culture:

Venus Concept believes in pushing boundaries while embracing creativity and innovation. Our employees are a critical part of our company’s performance and are at the core of its success. At Venus Concept, we rely on our employees, customers, and network of industry professionals around the world to continuously improve and Deliver the Promise. In order to do that, we ensure that everyone operates with the same values and vision.  At Venus Concept, we promise to give you Endless Opportunities, allow you to Foster Innovation and be part of Delivering a Best-In-Class Offering.

Venus Concept is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. Venus Concept is committed to accommodating persons with disabilities. Accommodations are available on request for qualified candidates during each stage of the recruitment process.

About Venus Concept
Venus Concept is an innovative global medical aesthetic technology leader with a broad product portfolio of minimally invasive and non-invasive medical aesthetic technologies and reach in over 60 countries and 29 direct markets. Venus Concept focuses its product sale strategy on a subscription-based business model in North America and in its well-established direct global markets. Venus Concept’s product portfolio consists of aesthetic device platforms, including Venus Versa™, Venus Legacy™, Venus Velocity™, Venus Fiore™, Venus Viva™, Venus Freeze Plus™, and Venus Bliss™. Venus Concept’s hair restoration division includes NeoGraft®, an automated hair restoration system that facilitates the harvesting of follicles during a FUE process and the ARTAS® and ARTAS iX™ Robotic Hair Restoration Systems, which harvests follicular units directly from the scalp and create recipient implant sites using proprietary algorithms.  The company has expanded its subscription platform and is now selling its devices in over 60 countries, including 29 with direct offices. Venus Concept now has over 500 global employees whose customer-centric approach has supported the company's rapid growth. For more information, please visit www.venusconcept.com.


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