Position Overview

Plans and directs the analysis of complex processes to be solved with Quality Management System (QMS) applications. Provides guidance in identifying, evaluating and developing systems and procedures that are cost-effective and meet user requirements. Plans and
executes user acceptance testing; and collaborates with business process owners to develop specifications for systems to meet business requirements. Job duties:

  • Responsible for leading the Quality Management System (QMS) implementation, enhancements, upgrades, and on-going maintenance to ensure alignment with business requirements and in compliance with applicable guidelines and regulations.

  • Serve as a liaison between business process owner (BPO) and application specialist (IT) on requirements and issue resolution.

  • Serve as a PM for smaller scale projects (system enhancement/ QMS reports).

  • Gather detailed user requirements and provide proposals for alternate solutions based on intended use and system capability.

  • Develop test scripts and coordinate user acceptance testing (UAT) activities and execution of validation protocol.

  • Assist with training material and work instructions for users.

  • Develop applicable business reporting per user requirements.

  • Keep abreast with regulatory requirements related to QMS software.

  • Performs additional responsibilities as assigned.

    1. Bachelor’s degree in IT, Engineering or other relevant discipline or equivalent experience.

    2. Minimum of three (3) years of experience in medical device software regulations, including involvement with electronic records, electronic signatures and validating software applications.

    3. Successful experience working independently, effectively and confidently in a team environment.

    4. Knowledge of General Principles of Software Validation (GPSV).

    5. Knowledge of 21CFR11, 21CFR820 and ISO 13485.

    6. Excellent written and verbal communication skills.

    7. Proficient with MS Word, Excel, PowerPoint and Outlook.

    8. Ability to determine the required test cases during SW validation.

    Desired Qualifications

    1. Knowledge of AAMI TIR36, GAMP 5, IEC 62304, ISO 14971, ANSI/AAMI/IEC 62304, ANSI/AAMI/IEC TIR80002-1, AAMI TIR45.

    2. Knowledge of Guidance for Industry, FDA Reviewers and Compliance on OTS SW Use in Medical Devices.

    3. Project management skills with the ability to motivate cross-functional teams to complete their assigned tasks.

    4. Ability to present SW validation strategies and obtain alignment from stakeholders (i.e. upper management).

    5. Demonstrated skills in developing risk-based master validation plans, test protocols, and preparing test reports.

    6. Ability to translate regulation requirements into practical validation plans.