With over 400M connected medical devices worldwide and the value of the healthcare Internet of Things (IoT) market valued at $163 billion, it’s no surprise that venture funding in the Digital Health space has hit record highs year after year. What’s clear is that all of healthcare’s future products – medical devices, combination products, wearables, Software as Medical Device and more – will all be digitally driven.

A leader in the digital health space is BrightInsight, the VC-backed Silicon Valley startup that provides the leading global regulated IoT platform for the world’s top biopharma and medtech companies.

We are a team of experienced professionals who have first-hand experience building and scaling digital health solutions within the regulated healthcare space. We are passionate about what we do and wholeheartedly believe in our vision to transform patient outcomes globally by bringing the power of digital technology to healthcare.

Since launching the BrightInsight Platform in 2018, we have secured a number of top-tier customers, including announcements with 4 of the world’s top 20 biopharma companies. Our award-winning platform was selected as the “Best IoT Healthcare Platform” in the 2019 MedTech Breakthrough Awards, Google Cloud’s Partner of the Year for Healthcare for two consecutive years, was featured as the cover story for CIOReview Magazine’s “20 Most Promising Biotech Solution Providers 2019," and was included in The Journal of mHealth's “2020 Global Digital Health 100”.

If you enjoy working with solution-oriented, driven colleagues in an agile, beaurocratic-free environment, then come join us at BrightInsight.  

Position Summary

The Quality Assurance - Document Control and Training  will be based in San Jose (or home base within the United States) and is a multi-functional role. The Sr. Quality Assurance Engineer - Document Control and Training is an specialist with extensive level of expertise and experience in document control and training management, has a general knowledge of pharmaceutical and/or medical device industry and a good understanding of GxP and safety standards.

Quality Assurance - Document Control and Training will assist in the administration of TrackWise DMS and TMS, ensure adherence to the Document Control and Training processes within BrightInsight Quality Management System requirements for adherence to ISO13485:2016, 21CFR820, MDSAP, 21CFR Part 11 and other applicable regulatory standards.

The Quality Assurance - Document Control and Training will work with other departments to plan, develop, author, edit, format, illustrate, update and create new standard operating procedures and other related documentation such as work instructions, formats, forms, logs and technical reports in support of the BI QMS.

This role will coordinate document control transactions, site record retention, and support other quality departments like Complaint, CAPA, Supplier and Customer Audits, and QMS periodic review. 

We are looking for someone who thrives in a start-up environment and demonstrates:

    • Intensely collaborative
    • Passionately focused on the customer
    • Disciplined executor of responsibilities
    • Tenacious commitment to continuous improvement
    • Relentless drive to win
    • Intense curiosity on technology
    • Flexibility and willingness to learn
    • Self motivated

 

Here is a glimpse of your duties…

    • Managing documentation workflows to meet department needs
    • Coordinate training activities for BI employees and contractors
    • Create new document type and projects groups within TrackWise
    • Coordinate training of staff, contractors, and customers in TrackWise DMS/TMS
    • Administrating TrackWise Digital Document Management System (DMS) and Training Management System (TMS)
    • Serve as liaison between TrackWise team and BrightInsight for the DMS/TMS module
    • Maintenance and retrieval of records to support audits, inspections, and investigations, issuing documentation to respective department requestors.
    • Manage and validation of changes in TrackWise DMS/TMS modules
    • Assist on the planning and execution of the QMS Annual review.
    • Coordinate collection and compilation of slides for management review meetings.
    • Generate meeting minutes for deviations, change control board, etc.

 

Here is some of what you’ll need (required)…

    • Bachelor's degree in engineering, science or related area of study, or equivalent work experience.   
    • Experience working 5 years within the medical device/pharmaceutical industry in a similar position is required.
    • Strong knowledge of document and training management experience in a GxP environment.
    • Experience writing GxP standard operating procedure and adherence to regulatory requirements.
    • Good understanding on ISO 13485, 21 CFR Part 820, 21CFR Part 11, MDSAP and MDR (EU) is required.
    • Excellent writing and presentation skills

 

Here are a few examples of what you’ll get for the great work you provide:

  • Full range of medical benefits, dental, vision, etc.
  • Life Insurance
  • Matching 401K
  • Paid Time Off

 

BrightInsight is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. BrightInsight does not discriminate in employment opportunities or practices on the basis of: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status or any other status protected by law. BrightInsight provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. BrightInsight will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with BrightInsight.

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