Be part of
rethinking the
future of
healthcare.

Be part of
rethinking the
future of
healthcare.

At VitalConnect, our common mission is to save lives and enhance patient care by providing elegant monitoring solutions. We invite you to come join us in making a difference.

Current Openings



Principal Quality Systems Engineer

Location: San Jose, CA
Date Posted: 05-02-2018
Principal Quality Systems Engineer

VitalConnect is delivering a revolutionary solution for in hospital and outpatient care to address the growing need for patient data connectivity. VitalConnect leverages extensive expertise in biomedical engineering, data analytics, chip design, and mobile and cloud software to create technology that supports decision-making paradigms that achieve better health and economic outcomes. VitalConnect’s products are designed for use in a broad range of inpatient and outpatient settings, such as hospital monitoring, post-discharge care, cardiac monitoring and pharmaceutical solutions.
 
We’re looking for people who are passionate about revolutionizing healthcare with digital technology. Are you a top performer looking for a dynamic atmosphere with a lot of freedom and responsibility? We want to hear from you!

The Principal Quality System Engineer will be responsible for the day-to-day management and execution of the Quality System within the organization.  This hands-on position will actively maintain all aspects of 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:
•    Ensuring VitalConnect’s regulatory compliance with FDA Quality System Regulations, ISO 13485, ISO 14971, IEC 62304, MDD, and other applicable regulatory standards.  
•    Responsible for reviewing internal documentation to ensure compliance with VitalConnect’s processes and policies.  
•    Responsible for Complaint handling, CAPA, NCR's, Supplier Management (including SCA's), Post Market Surveillance and Quality Metrics
•    Prepare materials for management review, including meeting minutes and following up on action items to ensure they are 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 in 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 years’ experience in the medical device industry
•    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 Vital Connect for employee and dependents!
•    Pre IPO Stock
•    Annual holiday shutdown from Christmas to New Years!
•    Lunch catered daily (TOGO's, Premier Pizza, Subway, Gotta Eatta Pitta, Rangoli India, Panda Express, BBQ, and many more!)
•    Morning snacks provided (Hi5 Fruit, Whole Foods, Noah's Bagels, Hobee's)
•    Free on-site gym
 
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