Be part of
rethinking the
future of
healthcare.

Be part of
rethinking the
future of
healthcare.

At VitalConnect, we’re all united in a common goal: to help advance the frontiers of healthcare and make a real difference in people’s lives. We invite you to come join us in making that difference.

Current Openings



Manager of Quality Systems

Location: San Jose, CA
Date Posted: 07-24-2017
LOCAL CANDIDATES ONLY. IF YOU ARE LOCATED OUTSIDE OF THE CALIFORNIA BAY AREA, PLEASE DO NOT APPLY.

VitalConnect is a medical device company designing and manufacturing state-of-the-art biosensor technology to gather, store and analyze biometric data. VitalConnect partners with healthcare providers to offer continuous, wireless vital signs and activity monitoring for their patients. We’re looking for people who are passionate about revolutionizing healthcare with digital technology. This is an opportunity to work with the latest-generation of FDA-cleared wearable sensors in the rapidly developing mobile health market.
 
Are you a top performer looking for a dynamic atmosphere with a lot of freedom and responsibility? We want to hear from you!

The Manager of Quality Systems will be responsible for the day-to-day management of the Quality System within the organization.  The position will actively monitor and maintain the Quality System to ensure compliance with the regulatory and regional requirements applicable to VitalConnect. The position will directly interface with Operations and R&D.
 
Responsibilities include:
  • Ensuring Vital Connect’s regulatory compliance to FDA Quality System Regulations, ISO 13485, ISO 14971, IEC 62304, and other applicable regulatory standards. 
  • Responsible for reviewing internal documentation to ensure compliance to Vital Connect’s processes and policies. 
  • Responsible for Complaint handling, CAPA, NCRs, Supplier Management (including SCAs), Post Market Surveillance and Quality Metrics
  • Prepare materials for management review, including meeting minutes and following up on action items to ensure completed
  • Provide quality review and authorship for standard operating procedures and quality review of design history file documentation and design reviews.
  • Provides direction to ensure adequate support is provided to Operations for the development, modification and qualification of manufactured components.
  • Drive compliance of the supply chain through supplier audit, process control, and inspection
  • Actively participate during audits by competent authority, regulatory agencies, and corporate partners.
  • Assigned as back-up Management Representative
  • Other duties as assigned
EXPERIENCE/EDUCATION
Minimum Qualifications:
  • B.S. or higher degree
  • 8 yrs experience in the medical device industry
  • 5 yrs in medical device quality management
  • Strong documentation skills
  • Ability to influence team members with diverse technical backgrounds
Benefits at VCI include:
  • Employee Medical, Dental, and Vision benefits paid 100% by VitalConnect
  • Pre IPO Stock
  • Lunch catered daily (Erik's Deli, Panda Express, Subway, Premier Pizza, Rangoli India, Opa! Chinese, BBQ, and many more!)
  • Morning snacks provided (Hi5 Fruit, Whole Foods, Bagel Street Cafe, YumYum Donuts)
  • Free on-site gym
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