Senior Manager, Design Quality Assurance
Sibel Health
Design, Quality Assurance
Chicago, IL, USA
Posted on Oct 6, 2025
This job was posted by https://illinoisjoblink.illinois.gov : For more
Information, Please See
https://illinoisjoblink.illinois.gov/jobs/13021601
Manage the development and implementation of a comprehensive software
design quality strategy aligned with Sibel Healths missions and goals,
and regulatory requirements.
Provide governance for software design quality throughout the product
development lifecycle, fostering a culture of quality, continuous
improvement, and compliance.
Manage and oversee all aspects of design quality assurance activities,
including design verification and validation, and risk management, in
compliance with applicable regulatory standards such as ISO 13485, IEC
62304, and FDA 21 CFR Part 820.
Ensure robust design control processes are in place, including design
reviews, design history files (DHF), and design transfer activities.
Guide cross-functional teams, including R&D, manufacturing, regulatory
affairs, clinical, and product management, to ensure seamless
integration of quality assurance processes for software development
projects.
Develop and maintain quality metrics, key performance indicators (KPIs),
and reporting systems to monitor and enhance product quality and
reliability.
Ensure compliance with global regulatory requirements and standards for
software development and design controls, as established by agencies,
including but not limited to the FDA, EU Commission, TGA, Health Canada,
and other relevant regulatory bodies.
Lead internal and external audits, inspections, and assessments,
addressing any findings or non-conformances promptly and effectively.
Implement robust corrective and preventive action (CAPA) processes to
address product quality issues and drive continuous improvement.
Information, Please See
https://illinoisjoblink.illinois.gov/jobs/13021601
Manage the development and implementation of a comprehensive software
design quality strategy aligned with Sibel Healths missions and goals,
and regulatory requirements.
Provide governance for software design quality throughout the product
development lifecycle, fostering a culture of quality, continuous
improvement, and compliance.
Manage and oversee all aspects of design quality assurance activities,
including design verification and validation, and risk management, in
compliance with applicable regulatory standards such as ISO 13485, IEC
62304, and FDA 21 CFR Part 820.
Ensure robust design control processes are in place, including design
reviews, design history files (DHF), and design transfer activities.
Guide cross-functional teams, including R&D, manufacturing, regulatory
affairs, clinical, and product management, to ensure seamless
integration of quality assurance processes for software development
projects.
Develop and maintain quality metrics, key performance indicators (KPIs),
and reporting systems to monitor and enhance product quality and
reliability.
Ensure compliance with global regulatory requirements and standards for
software development and design controls, as established by agencies,
including but not limited to the FDA, EU Commission, TGA, Health Canada,
and other relevant regulatory bodies.
Lead internal and external audits, inspections, and assessments,
addressing any findings or non-conformances promptly and effectively.
Implement robust corrective and preventive action (CAPA) processes to
address product quality issues and drive continuous improvement.