Remote Principal Post-Market Sustaining Quality Engineer

Cordis, LLC; Irvine (CA); Vor Ort; USD 140.000 - 210.000; Vollzeit

Zusammenfassung

Cordis, LLC in Irvine, CA seeks a Principal Sustaining Quality Engineer (Post-Market) to ensure medical devices meet safety and regulatory standards after launch. You will lead post-market activities, investigations, and risk management, driving continuous improvement across PMS, CAPA, and reporting.

The role requires 8+ years in medical device quality, strong technical writing, and fluency in English, with travel up to 20% for domestic and international sites.

Qualifikationen

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

Aufgaben

• Develop, maintain, and execute post-market plans, procedures, and reporting activities; ensure compliance with FDA, EU MDR, MDSAP, ISO 13485, and other standards.
• Drive product and process improvements; execute programs from component optimization to next-generation processes.
• Maintain and influence Risk Management Files by evaluating post-market information and potential safety impact.
• Lead or support investigations into complaints, nonconformities, malfunctions, and field performance issues; analyze data for trends.
• Establish and maintain post-market metrics, dashboards, and management-review inputs.
• Support field actions, recalls, safety notices, and customer communications when required.
• Participate in internal, supplier, and regulatory audits; prepare post-market documentation and respond to observations.
• Maintain awareness of applicable regulations, standards, and industry guidance.
• Perform other duties as assigned.

Ausbildung

Biomedical/Mechanical Engineering (Bachelor’s)

Jobbeschreibung

Cordis, LLC in Irvine, CA seeks a Principal Sustaining Quality Engineer (Post-Market) to ensure medical devices meet safety and regulatory standards after launch. You will lead post-market activities, investigations, and risk management, driving continuous improvement across PMS, CAPA, and reporting.

The role requires 8+ years in medical device quality, strong technical writing, and fluency in English, with travel up to 20% for domestic and international sites.