QA Associate/Quality Inspector - San Jose, California, USA

QA Associate/Quality Inspector - San Jose, California, USA

Title:                  QA Associate/ Quality Inspector

Reporting to      Sr. QA Manager

Location:            San Jose, California, USA

 

 

Responsible for day-to-day support 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 requires flexibility, initiative, ability to work well with others and willingness to take on new responsibilities.

Responsible for the process of addressing quality concerns, maintaining the documentation system, and monitoring compliance with standard operating procedures, and ISO 13485 management. an experienced and highly analytical quality inspector to join our production department. As the quality inspector, you will uphold the safety regulations of our company and supervise the production process to guarantee that all our products meet quality expectations

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:

  • Conduct inspections according to approved procedures/specifications.
  • Read and understand datasheets and component specifications, ability to verify RoHS compliance, Certificate of Conformances (CoC) and Certificate of Analysis (CoA).
  • Measure product dimensions, examine functionality, and compare the final product to the specifications.
  • Perform regular quality assessments on all incoming materials from vendors and outgoing products for shipping.
  • Coordinate Material Review Board (MRB) meetings to determine disposition of the nonconforming material.
  • Tracks the status of incoming materials, ensures computer databases/worksheets are updated and keeps QA Manager and other appropriate departments informed of inspection status.
  • Document inspection outcomes by completing detailed reports and performance records.
  • Conducts quality investigations for non-conforming product and recommends corrective action / preventative action (CAPA) plan.
  • Recommend improvements to the production process to ensure quality control.
  • Assist and ensure the Quality Management System and regulatory compliance requirements are effectively maintained, implemented and monitored.
  • 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:

  • BS Engineering (preferred) or related technical area, or 2-5 years of Quality Systems or Engineering experience.
  • Knowledge of ISO 13485, FDA QSR requirements required
  • Complaint Handling and Corrective and Preventive Actions (preferred)
  • Experience with Document Control Systems (Agile or Arena PLM preferred) and Enterprise Resource Planning (Salesforce. Priority ERP)
  • CAD proficiency, preferably SolidWorks
  • Must have ability to process, analyze and present data
  • Excellent oral and written communication skills required

 

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 and hair restoration technologies and reach in over 60 countries and 18 direct markets. Venus Concept focuses its product sales 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 Freedom, Venus Viva, Venus Freeze Plus, Venus Glow, Venus Bliss, Venus Epileve and Venus Viva MD. Venus Concept’s hair restoration systems include 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 harvest follicular units directly from the scalp and create recipient implant sites using proprietary algorithms. Venus Concept has been backed by leading healthcare industry growth equity investors including EW Healthcare Partners (formerly Essex Woodlands), HealthQuest Capital, Longitude Capital Management, and Aperture Venture Partners.

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Thank you for your interest in joining the Venus Concept team. Please fill out the form below and we will get in touch if it's the right match.

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