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Senior Post-Market Quality Manager at Synthesis Health - ApplyBlast

Senior Post-Market Quality Manager

Synthesis Health

1 month ago

Remote

Full Time

Senior

22 applicants

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About this role

Synthesis Health is seeking a Senior Post-Market Quality Manager to lead and improve post-market quality processes for Software as a Medical Device (SaMD) products. This role involves managing the full post-market lifecycle, including complaint handling, adverse event assessment, trend analysis, and CAPA, while ensuring compliance with MDSAP and other regulatory standards. The position requires close collaboration with cross-functional teams to identify, investigate, and resolve product quality and safety issues.

Responsibilities

Lead post-market quality processes and program for Software as a Medical Device products
Investigate product complaints, adverse events, and nonconformances to identify root causes
Develop and oversee corrective and preventive actions to resolve quality issues

Skills

Qualifications

MDSAP Quality Management SystemsISO 13485MDSAP program

About Synthesis Health

synthesis.health

Headquarters

Vancouver, British Columbia, Canada

Company Size

51-200 employees

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Synthesis Health is an emerging leader in imaging software and AI, partnering with radiology departments, medical imaging centers, hospitals, and physician practices. They develop imaging software and AI-driven solutions designed to streamline diagnostic workflows, enhance image analytics, and support clinical decision‑making. Their products integrate with existing clinical systems and imaging infrastructure to enable scalable deployment across health systems. Synthesis Health focuses on improving efficiency, accuracy, and patient outcomes through technology and partnerships.