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, bureaucratic-free environment, then come join us at BrightInsight.

The  Site CAPA Coordinator supports compliance with applicable regulatory requirements by maintaining and monitoring of information relative to problem statements, root cause analysis, corrections, corrective, and preventative actions, tracking of timelines, and establishing CAPA files. This position is responsible for collaborating with Engineering, Operations, and other functional groups to ensure quality performance of various software medical devices solutions.

These solutions include cloud-based applications, mobile, web, and web services that leverage the capabilities of the BrightInsight platform. The BrightInsight platform is a medical IoT, cloud-based platform for the life science industry, and is used to manage, process, and store patient health and medical device data to be used for patient diagnosis and treatment.

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

  • Intensely collaborative
  • Passionately focused on the customer
  • Detail oriented
  • Disciplined executor of responsibilities
  • Tenacious commitment to continuous improvement
  • Relentless drive to win
  • Intense curiosity on technology

Here is a glimpse of what you will do…

  • Participate in the implementation of the CAPA software solutions program.
  • Administrative duties include but are not limited to the monitoring of information relative to problem statements, root cause analysis, corrections, corrective and preventative actions, tracking of timelines, and establishing CAPA files.
  • Serve as a resident point of contact in CAPA regulatory/compliance.
  • Monitor the effectiveness of the CAPA system.
  • Coordinate all needed training for users of the CAPA system.
  • Serve as the coordinator of the CAPA meetings.
  • Trend CAPA metrics and present defined reports at specified intervals. Present CAPA information during Management Reviews.
  • Maintain and revise applicable procedures as necessary.
  • Assist/Interface with CAPA owners on CAPA Investigations and Action Plans.
  • Conduct training on CAPA tool usage
  • Maintain and improve the quality system in accordance with but not limited to FDA Quality System Regulation, MDSAP, EU MDR, ISO 13485 requirements etc.
  • Assist with the notified body and regulatory authority audits and inspections.
  • Other duties/ activities may be necessary to support departmental or company goals

Here is some of what you will need (required)…

  • A minimum of 4-7 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device)
  • BS degree in Engineering or Lifesciences
  • Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971)
  • Experience with all aspects of modern quality control/assurance techniques such as, non-conformances, corrective/preventative action plans, root cause investigations.
  • Familiarity with SaMD/software-only medical device development
  • Familiarity with all aspects of modern quality control/assurance techniques such as, corrective/preventative action plans, root cause investigations.
  • Excellent time management skills and organization skills
  • Familiarity with computer usage and application such as (Microsoft Access, PowerPoint, Excel)
  • Ability to exercise good judgment in determining the reasonableness of actions.
  • Ability to work with minimum supervision.
  • Innovative with the ability to make sound suggestions for improvement.
  • Possess effective presentation and writing skills

 

Travel

  • Position can require up to 30% travel 

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, religious belief, color, sex, national origin, marital status, sexual orientation, gender identity, disability, pregnancy status or any other status protected by law. BrightInsight makes reasonable adjustments 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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