: Process Quality Engineer

Process Quality Engineer

TriNetX is the Global Health Research Network for Healthcare Organizations (HCOs), Biopharma, CROs and Patients. TriNetX combines real-time access to clinical data, state-of-the-art analytics, and a global network of researchers, research sites and sponsors to enhance trial design, optimize site selection, accelerate patient recruitment, gather and curate real-world data, and generate real-world evidence in support of pre and post approval activities.

The Process Engineer position will work within the TriNetX Security & Compliance Group and liase with the newly formed Security Operations Center (SOC).The purpose of this role is to ensure Product Quality and drive process improvements through the implementation of a Healthcare Quality Management System (QMS) with underlying focus on Information Security.

Primary Role

  • Lead the implementation of a Healthcare Quality Management System (QMS) where it impacts any GxP compliant TriNetX Products and systems to assure it is aligned with regulatory expectation
  • This role shall ensure that software developed at TriNetX which is expected to be GxP compliant operates within the framework of applicable health authority regulations including but not limited to Code of Federal Regulations 21 CFR part 11 and Computer System Validation guidelines provided by the Food and Drug Administration (FDA)
  • Develop improved processes to analyze product quality and make recommendations for change
  • Create and update documentation (SOP, IQ, OQ, PQ) as well as templates to support the QMS
  • Provide quality engineering support and approval of verification and validation strategies, activities, protocols, reports, etc
  • Work together with relevant teams and departments to improve quality and ensure products adhere to Company, Industry and Regulatory quality standards
  • Brainstorm ideas to create solutions for identified problems
  • Perform Inspections and document findings
  • Perform continuous research and data analysis tasks in relation to process improvements
  • Create and update the company's quality standards and testing systems to reflect efficiency, reliability and performance

Secondary Role

  • Provides strategic direction for the Security Operations team, and Security Analysts team responsible for daily security operations and drive repeatable process automation allowing for the utilization of SOC Resources for higher critical thinking procedures
  • Make recommendations, create, modify, and updates SOC procedures in order to improve TriNetXs security posture
  • Assessment and modification of the TriNetX Threat Management processes
  • Develop Playbooks for SOC Tier 1/2/3 teams to follow on a daily basis
  • Audit the SOC for compliance with ISO 27001:2013 , HIPAA Security Rule, GDPR Article 32 etc.

Required Skills and Experience

  • Bachelors Degree in engineering
  • 5+ years of experience in Quality Assurance and/or Regulatory Affairs for regulated computer software in the Healthcare vertical
  • 3+ years of experience with QMS implementation that complies with FDA 21 CFR Part 11 and FDA Computer System Validation (CSV)
  • Certified Quality Engineering - ASQ certification preferred (CQE)
  • Knowledge of HIPAA/HITECH, GDPR, CCPA and other Global Privacy Laws
  • Knowledge of ISO 27001:2013, ISO 9001, IEC 62304 are highly desirable
  • Experience with ITIL Procedures (Change, Incident, Problem Management etc.)
  • Experience of working with a NOC/SOC preferred
  • Strong skills in time management, project management, communication (written / verbal) and organization
  • Excellent interpersonal skills, dependability, and the ability to communicate with all levels in the organization
  • Technical agility that allows you to keep management, your peers, and your customers apprised of risks, issues, and overall status
  • Be a self-starter, take initiative, and work independently but not in isolation
  • Position level will be determined by candidate's experience