Title: Executive Consultant – Medical Device Electronics, Electromechanical QA/RA

To apply, email resume and cover letter to hr.tech@orielstat.com. Please put ELECin the subject line.

Position Description

The Director – Medical/In Vitro Device Software Quality Consulting is responsible for planning and delivering life science software consulting engagements related to quality/regulatory affairs infrastructure. This role is also expected to contribute to the development of software verification and validation of intellectual property. Consulting engagements will cover both software embedded into devices and software in stand-alone solutions to be used alongside devices.

Person Description

  • Already recognized as an expert by peers and industry professionals
  • Projects a confident personality and is competent in effectively getting ideas across to others
  • Demonstrates an ability to work in a team environment, especially when operating remotely
  • Has a passion for patient safety through effective quality assurance and regulatory affairs activities
  • Respects the contributions of all colleagues and facilitates consensus on tough issues
  • Demonstrates flexibility in both day-to-day work with the team and approaches to unique client issues
  • Is able to assimilate diverse data, think critically, and solve problems
  • Has a strong understanding of existing and emerging global regulations concerning patient and data privacy
  • Has a strong understanding of the threat of and activities to mitigate cybercrime
  • Can provide evidence of experience with 15 or more medical devices
  • Major plus: Has the ability and desire to provide formal training courses in some or all these topics

Basic Qualifications

  • Bachelor’s degree in life sciences, software, or electrical engineering or a related field; master’s degree preferred
  • Can provide evidence of progressively taking more responsibility and leading activities in management or as a high-level individual contributor
  • Ability to get ideas across in a workshop format, and adept at engaging participants in the subject
  • Has delivered 15 or more highly technical consulting engagements in QA/RA functions

Industry Requirements

  • Experience with FDA 21 CFR 820, ISO 13485, EU MDR, and working with Notified Bodies
  • Experience with remediation of technical documents, CAPA activities
  • Major plus: Experience with high-grade laser products

Travel: Occasional international travel may be required when conditions allow.

To Apply To apply, email your resume and a cover letter to hr.tech@orielstat.com. Please place Job Code: “ELEC” in the subject line.

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Oriel STAT A MATRIX is an Equal Opportunity Employer.