Associate Software Quality Engineer

Key Responsibilities

• Support the preparation and maintenance of

  Technical Documentation

  in compliance with

  IEC 62304

  and

  IEC 82304

  standards for

  Software as a Medical Device (SaMD) and (SiMD)

  ,

  EU MDR

  ,

  FDA QSR (21 CFR 820)

  , and related regulatory requirements.
• Contribute to the

  software development lifecycle documentation

  as per IEC 62304 and organizational quality processes.
• Assist in defining and maintaining

  software risk management documentation

  aligned with

  ISO 14971

  and

  IEC 62304

  .
• Collaborate with

  cross-functional teams

  (Development, Quality, and Regulatory) to ensure

  traceability, accuracy, and completeness

  of design and verification artifacts.
• Review and update

  software lifecycle documentation

  , including

  requirements, architecture, verification, validation

  , and

  release records

  .
• Ensure compliance with

  cybersecurity

  ,

  usability (IEC 62366)

  , and

  data integrity (21 CFR Part 11)

  requirements.

Required Skills

• 15 years of experience in

  medical device software development

  or a

  regulated environment

  .
• Strong understanding of

  IEC 62304

  ,

  ISO 13485

  ,

  ISO 14971

  , and

  IEC 82304-1

  standards.
• Hands-on experience with

  SiMD

  (Software in a Medical Device) and

  SaMD

  (Software as a Medical Device) documentation and regulatory submissions.
• Excellent

  communication

  ,

  documentation

  , and

  cross-functional collaboration

  skills.