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Paige.Aiposted 2 months ago
$119,789 - $139,789/Yr
Full-time - Mid Level
Remote - New York, NY

About the position

The Senior Quality & Compliance Engineer at Paige.AI, Inc. is responsible for ensuring compliance with the In Vitro Diagnostic Regulation (IVDR) and other relevant standards for medical device software components. This role involves leading risk assessments, collaborating with cross-functional teams to maintain a robust quality management system (QMS), and preparing for regulatory audits. The position requires a strong understanding of quality regulations and the ability to implement corrective actions to resolve quality issues.

Responsibilities

  • Develop and maintain an in-depth understanding of the In Vitro Diagnostic Regulation (IVDR) and its specific requirements related to medical device software components to ensure compliance.
  • Lead risk assessment activities related to software development used in medical devices, including hazard analysis, risk management plans, and mitigation strategies.
  • Collaborate with cross-functional teams to establish and maintain a robust quality management system (QMS) of medical devices that complies with IVDR and other relevant standards, such as ISO 13485.
  • Investigate and resolve quality issues through root cause analysis, implement corrective and preventive actions (CAPA), and address non-conformance issues.
  • Write detailed operating procedures and work instruction-level documents for the QMS.
  • Identify opportunities for process improvements and best practices in software quality engineering and implementation.
  • Prepare for and support regulatory audits and inspections related to IVDR and other quality standards and manage audit and inspection readiness projects.
  • Prepare and maintain documentation necessary for regulatory submissions, including technical files and design dossiers, while ensuring project documentation is up to date.

Requirements

  • Bachelor's degree in Biomedical, Software, Chemical, Processing, Systems, or Quality and Compliance Engineering, or a closely related field.
  • Three (3) years of work experience as a Software as a Medical Device (SaMD) quality systems engineer or closely related occupation.
  • ISO 13485 certificate.
  • Demonstrated ability conducting and leading internal audits and leading external audits within a Software as a Medical Device (SaMD) regulated environment gained through two (2) years of work experience.
  • Demonstrated ability working within software methodologies (e.g., agile practices), software validation, and project management tools gained through two (2) years of work experience.
  • Demonstrated ability working within quality regulations and standards relevant to medical devices, including 21 CFR 820, EU IVDR 2017/746, MDSAP, and CMDR SOR/98-282, gained through two (2) years of work experience.
  • Demonstrated ability applying problem-solving and analytical skills to investigate root causes and resolve quality issues, analyzing and implementing corrective and preventive actions (CAPA), and addressing non-conformances (NC) and internal/external audit findings gained through two (2) years of work experience.
  • Demonstrated knowledge of In Vitro Diagnostic Regulation (IVDR) gained through at least one year of work experience.
  • Demonstrated project management ability, including risk management, quality management, and regulatory submissions, gained through at least two (2) years of work experience.

Benefits

  • Telecommuting options available.
  • Competitive salary range of $119,789 to $139,789 USD per year.
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