QMS Manager/Engineer

QMS Manager/Engineer

QMS Manager/Engineer

Reports to:  Senior Manager, Quality

Location:  San Jose, California

 

We have an exciting opportunity for a full-time QMS Manager/Engineer to join our growing team in the Medical Aesthetics Industry!  Reporting to the Senior Manager of Quality, the QMS Manager/Engineer will be based in our San Jose Office and will be responsible for operating the Quality Management System (QMS), writing procedures and processes to support the QMS development. Lead and undertake audits across all areas of the business as well as across the supply chain. Provide training and champion the Quality Management System.

Responsible for the process of addressing quality concerns, maintaining the documentation system, and monitoring compliance with standard operating procedures, and ISO 13485 management.

Applies job skills and company policies and procedures to work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.  Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criterion for obtaining results.

 

What you will do:

  • Support the implementation of new processes and procedures, including the selection and implementation of a new electronic QMS and maintenance all QMS content and master files.
  • Assist and ensure the Quality Management System and regulatory compliance requirements are effectively maintained, implemented, and monitored.
  • Monitors quality issues, identifies actions needed to correct, highlights issues to management and drives corrections.
  • Interfaces with R&D and Operations and other area Managers to implement process improvements.
  • Monitors compliance with standard operating procedures and ISO/QSR requirements.
  • Provide continuous assessment of the Quality Management System including CAPA, internal audit, management reviews 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.
  • Participate and lead internal compliance audits and on-site audits of customers and vendors.
  • Administer the Corrective and Preventive Action Systems for customer feedback, supplier conformance and internal continuous improvement projects.

 

What you will need:

  • BS Engineering (preferred) or related technical area.
  • 2-5 years of Quality Systems or Engineering experience.
  • Knowledge of and 2-5 years of experience with Quality Systems regulations including 21 CFR 820 and ISO 13485.
  • High level of experience and understanding of GMP/GLP system requirements.
  • Experience with the execution of quality systems like CAPA, NCMR, deviations and document control.
  • Certified Internal Auditor (preferred).
  • Experience in medical devices is an asset.
  • Excellent skills in organization, record keeping and oral and written communications.
  • Ability to collaborate cross functionally and work in a team dynamic.
  • Proactive, self-motivated mindset.

 

 

What you will 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 22 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 22 with direct offices. Venus Concept now has over 400 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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