Manager, Post-Market Quality & Compliance

Job overview

The Manager, Post-Market Quality & Compliance role is remote across the United States and Canada, with annual compensation of $100,000–$120,000 USD. Synthesis Health’s remote team works to advance healthcare through innovation and collaboration. The manager leads and improves post-market quality processes for the company’s Software as a Medical Device products, addressing complaints, safety signals, corrective actions, and field actions. The role partners across regulatory, medical, product, engineering, and customer-support teams to investigate and resolve quality and safety issues.

What you'll do

• Own and improve post-market quality procedures and tools
• lead complaint assessments and investigations, risk assessments, root-cause analysis, and resolution
• evaluate reportability and patient or user impact
• monitor trends and maintain quality metrics
• ensure documentation and timely closure of records
• lead CAPAs and field actions
• assess software defects and changes for quality and safety implications
• support audits, regulatory compliance, inspection readiness, and QMS training.

What we're looking for

Skills & competencies

post-market quality manager

remote

synthesis health

software as a medical device

samd

quality management

mdsap

post-market surveillance

capa

radiology software

$100k–$120k

remote us and canada

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, and vision coverage, use-as-needed vacation policy, and participation in the employee option program.

Why this role

Fully remote role requiring a bachelor’s degree plus advanced MDSAP quality-system training or certifications and 6+ years of relevant quality experience. Focuses on post-market surveillance for radiology-related SaMD products.

About the employer

Synthesis Health is hiring for this role. Industry: Computer Systems Design Services. Sector: 54.