Position Overview

Leads the QMS software validation effort and ensuring the software implementation is aligned with business requirements and in compliance with applicable guidelines and regulations. Job duties:
  • Keep abreast with regulatory requirements related to QMS software implementation and translate regulation requirements into practical validation plans.
  • Establish and/or maintain software implementation framework/ governance, software development lifecycle (SDLC) methodology, validation procedure and work instructions to ensure compliance to all applicable regulations.
  • Develops and designs the validation plan for electronic Quality Management System (QMS).
  • Develop and implement a risk-based approach to computer systems testing/validation and explore the best software validation strategy to comply with business requirements, applicable guidelines and regulations.
  • Present SW validation strategies and obtain alignment from stakeholders (i.e. upper management).
  • Analyzes data, prepares and reviews test results and writes reports such as software traceability matrix and validation summary reports.
  • Provides advice or consultancy with respect to regulations and guidelines in the area of quality assurance for computer systems and data management.
  • Train associates to adhere to software implementation regulations/ requirements and validation processes.
  • Facilitate communication as a liaison with relevant department on requirements definition and issue resolution.
  • Serve as a subject matter expert (SME) on software compliance during audit.
  • Support supplier/ software vendor audit.
  • Performs other duties and responsibilities as assigned.
    1. Bachelor’s degree in IT, Engineering or other relevant discipline or equivalent experience.
    2. Five (5) or more years of experience in medical device software regulations, including involvement with electronic records, electronic signatures and validating software applications.
    3. Experience with General Principles of Software Validation, AAMI TIR36, 21CFR11, GAMP 5, 21CFR820, IEC 62304, ISO 14971, ANSI/AAMI/IEC 62304, ANSI/AAMI/IEC TIR80002-1, AAMI TIR45.
    4. Successful experience working independently, effectively and confidently in a team environment.
    5. Excellent written and verbal communication skills.
    6. Proficient with MS Project, Word, Excel, Outlook.
    7. Demonstrated skills in project management.
    Desired Qualifications
    1. PMP certification
    2. Successful experience working with various functional teams on software application projects.
    3. Demonstrated experience in medical product quality assurance.
    4. Excellent knowledge of medical device software regulations, including requirements for electronic records and electronic signatures.