Remote Senior Post-Market Quality & Compliance Lead

Synthesis Health; Huntington (WV); Remote; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Use as needed vacation policy

Employee option program

Job summary

Synthesis Health is seeking a Senior Post-Market Quality Manager to lead, implement, and continuously improve post-market quality processes for SaMD products. You will oversee complaint handling, CAPA, trend analysis, and field actions, partnering with Regulatory Affairs, Product, Engineering, and Customer Support to ensure timely resolution.

Ideal candidates bring extensive MDSAP experience, a deep understanding of SaMD quality considerations, and hands-on leadership without direct reports.

Qualifications

• Bachelor’s degree plus advanced training and certifications in MDSAP Quality Management Systems and post-market surveillance requirements.
• Knowledge of ISO 13485 and application in SaMD.
• Knowledge of MDSAP program and FDA/Health Canada/EUMDR regulations.
• Experience 6+ years in quality within healthcare or life sciences; audits, field actions, adverse event reporting.

Responsibilities

• Own and continuously improve post-market quality SOPs and tools for post-market surveillance.
• Lead investigation of product complaints with root cause analysis and CAPA.
• Monitor post-market data for adverse trends and quality metrics; report and act.
• Coordinate cross-functional CAPAs and drive corrective actions to closure.
• Provide quality guidance and training; represent post-market quality in reviews and audits.

Skills

Quality management

Auditing

Regulatory knowledge

Analytical skills

Cross-functional collaboration

Mentorship

Agile experience

Education

Bachelor’s degree + MDSAP QA certifications

Bachelor’s/Master’s in CS/Engineering or related

Job description

Synthesis Health is seeking a Senior Post-Market Quality Manager to lead, implement, and continuously improve post-market quality processes for SaMD products. You will oversee complaint handling, CAPA, trend analysis, and field actions, partnering with Regulatory Affairs, Product, Engineering, and Customer Support to ensure timely resolution.

Ideal candidates bring extensive MDSAP experience, a deep understanding of SaMD quality considerations, and hands-on leadership without direct reports.