Senior Post-Market Quality Engineer – Medical Devices

Cordis, LLC; Irvine (CA); On-site; USD 98,000 - 131,000; Full time

Job summary

Cordis, LLC in collaboration with Selution seeks a Senior Sustaining Quality Engineer (Post-Market) to ensure medical devices meet safety and regulatory standards after commercialization. You will drive post-market activities, investigations, and risk management across global markets.

The role requires 5+ years in PMS and quality systems, experience with cardiovascular products, and strong analytical and communication skills. Travel up to 20% may be required to support audits and field actions.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or related field.
• 5+ years of progressive experience in medical device, pharmaceutical, and/or combination-product industries with Post Market Surveillance, complaint handling, vigilance, adverse event reporting, and quality systems.
• Experience with implantable, interventional, catheter-based, drug-device combination, or cardiovascular products preferred.

Responsibilities

• Develop and maintain post-market plans, procedures, and reporting.
• Ensure post-market activities comply with FDA, EU MDR, MDSAP, ISO 13485, and other global standards.
• Lead investigations into complaints, nonconformities, malfunctions, and field performance issues.
• Maintain post-market risk management files and evaluate information to determine safety impact and reporting requirements.
• Establish and maintain post-market metrics, dashboards, and management-review inputs.
• Support field actions, product recalls, safety notices, and customer communications when required.
• Participate in internal, supplier, and regulatory audits and prepare post-market documentation.

Skills

Post-Market Surveillance

Data analysis

Investigation

Statistical methods

Regulatory compliance

Written communication

Independent decision-making

English fluency

Education

Bachelor’s degree in Biomedical Engineering or Mechanical Engineering

Job description

Cordis, LLC in collaboration with Selution seeks a Senior Sustaining Quality Engineer (Post-Market) to ensure medical devices meet safety and regulatory standards after commercialization. You will drive post-market activities, investigations, and risk management across global markets.

The role requires 5+ years in PMS and quality systems, experience with cardiovascular products, and strong analytical and communication skills. Travel up to 20% may be required to support audits and field actions.