Senior Post-Market Quality Engineer – Remote & Travel

RiseMe; Irvine (CA); Hybrid; USD 98,000 - 131,000; Full time

Job summary

Selution, in partnership with Cordis, is seeking a Senior Sustaining Quality Engineer (Post-Market) to ensure medical devices remain compliant, safe, and effective after commercialization. You will lead post-market activities and collaborate across Regulatory, Quality, R&D, and Operations.

The role requires 5+ years in medical device quality, PMS, complaint handling, vigilance, and post-market processes, with fluency in English. Travel up to 20% domestically and internationally is expected.

Qualifications

• 5+ years in medical device, pharmaceutical, and combination-product industries with PMS and post-market quality focus.
• Experience with regulatory reporting and complaint handling in regulated environments.
• Strong analytical and problem-solving skills with ability to work cross-functionally.

Responsibilities

• Develop and maintain post-market plans, procedures, and reporting aligned with FDA, EU MDR, ISO 13485, and other standards.
• Lead investigations into complaints, nonconformities, and field performance issues; analyze data for trends and risk.
• Establish post-market metrics, dashboards, and management-review inputs; support field actions and recalls when needed.
• Participate in internal, supplier, and regulatory audits; prepare post-market documentation and respond to observations.

Skills

PMS

Complaint handling

Vigilance

Quality systems

Data analysis

Statistics

Fluent English

Education

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Mechanical Engineering

Job description

Selution, in partnership with Cordis, is seeking a Senior Sustaining Quality Engineer (Post-Market) to ensure medical devices remain compliant, safe, and effective after commercialization. You will lead post-market activities and collaborate across Regulatory, Quality, R&D, and Operations.

The role requires 5+ years in medical device quality, PMS, complaint handling, vigilance, and post-market processes, with fluency in English. Travel up to 20% domestically and internationally is expected.