Quality Management System Manager

Location
Pleasanton, CA or Plano, TX
Posted
Dec 18, 2020
Required Education
Bachelors Degree
Position Type
Full time

AnX Robotica is looking for a QMS Manager in our Pleasanton, CA or Plano, TX office.  Our commitment to quality is at the heart of our brand and is vital to our growth and success.

Summary

The successful candidate will be experienced in working within the medical device industry, preferably startups, with knowledge in FDA Quality System Regulation (QSR), ISO 13485:2016, and other applicable standards and regulations. He/she should have good communication skills and the ability to take strategic direction and establish efficient and compliant processes throughout the company.

Responsibilities:

  • Develop, administer, and maintain QMS procedures and activities required to ensure that the company’s processes and products comply with all applicable quality standards, regulations, and requirements
  • Active participant in all stages of design development, V&V testing, and design control activities, ensuring quality considerations and requirements are met
  • Participate in the review of product requirements, design requirements, software requirements specifications, and functional specifications
  • Assist in risk management activities and failure investigations
  • Manage all aspects of internal training and qualification activities
  • Develop and implement quality control and inspection procedures for receipt and control of incoming materials and products, processing products, and final product acceptance and release activities
  • Assist in establishing and maintaining an effective complaint system
  • Manage the selection, approval, and monitoring of the company subcontractors and suppliers
  • Implement and monitor corrective and preventive actions (CAPA)
  • Identify and set quality metrics; analyze metrics to identify improvement opportunities, and report trends to management
  • Manage all aspects of internal audit program
  • Manage all aspects of external audits/inspections by certification bodies and regulatory agencies
  • Act as the management representative including organizing, running, and recording management review meetings and setting annual quality objectives and quality plan
  • Perform other tasks as assigned.

Qualifications:

  • Bachelor’s degree in biotech, science, or engineering from accredited college/university
  • CQE training/certification a plus
  • At least 3 years of experience working in a startup, entrepreneurial work environment
  • Knowledge of FDA QSR, ISO 13485, ISO 14971 and familiar with IEC 60601 series and other relevant standards
  • Comprehensive knowledge of quality tools for continuous improvement and investigations (e.g., cause & effect diagram, histogram, process maps, etc.); experience with Greenlight Guru software a plus
  • Understanding in software, electrical and mechanical engineering principles
  • Excellent verbal and written communication skills
  • High attention to detail and thoroughness
  • Ability to work in a team minded approach to achieve individual and company success
  • Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Microsoft Office Excel, Microsoft Office PowerPoint, and Microsoft Office Project programs
  • Fluent in both English and Chinese

Working Conditions:

  • Primarily in an office environment, with occasional time in laboratory/manufacturing areas
  • Domestic and international travel up to 20%

AnX Robotica Corp has developed the NaviCam™ System, a robotic control platform for gastrointestinal diagnosis and therapeutic applications. The NaviCam™ System utilizes advanced robotic technologies combined with innovative and intelligent software to give medical practitioners external control of capsules inside the human body.

AnX brings versatility in development and integration of multi-discipline technologies such as precise magnetic control, in house ASIC design, artificial intelligence, micro-optical imaging, image processing, and wireless transmission, etc. With more than 200 patents granted or applications pending, and dozens of clinical papers published in major international journals, AnX Robotica, together with its sister companies, have become a leading robotic capsule technology company by delivering more than 200,000 capsules to worldwide customers in 2019.

With the innovation of the NaviCam™ “Magnetically Controlled Capsule Endoscope System”, we had developed a new way of non-invasive complete visualization of the stomach with comparable performance to gastroscopy (EGD) – the gold standard. Our newest application of Artificial intelligence for the small bowel endoscopy (NaviCamTM SB) has been recognized as a “New Era for Diagnosis of Small Bowel Disease” on the cover page of the well-known journal “Gastroenterology” in October 2019. AnX Robotica Corp has also developed a product for constipation (VibraBotTM), a product for motility (IntraMarXTM), as well as additional products which the company will introduce over the next few years. AnX Robotica Corp is based in Texas and California with worldwide sales.