Supplier Quality Engineer II

About the role

We are looking for a Supplier Quality Engineer II to ensure that all incoming components and services meet the stringent safety and quality standards required in medical device and pharmaceutical manufacturing. The role will focus on supplier evaluation, audit, and continuous improvement to protect patient safety and product integrity.

Key responsibilities

• Perform supplier risk assessments and participate in supplier selection, evaluating quality systems, processes and services.
• Plan, conduct and follow‑up internal and supplier audits, maintaining up‑to‑date supplier profiles.
• Manage corrective action requests, non‑conformance reports, purchased part assessments and assess the impact of supplier change notifications.
• Update the Approved Supplier List and support the Material Review Board (MRB) process.
• Monitor, report and drive improvement of supplier quality performance.
• Oversee Quality Incoming and Release inspection activities, ensuring compliance with GMP, FDA, ISO standards and company procedures.
• Collaborate with suppliers on improvement programs and perform other duties as assigned.

Required profile

• Bachelor’s degree in engineering, science or a technical discipline.
• Minimum three years of supplier quality experience in a medical device or pharmaceutical manufacturing environment.
• ISO 13485 lead auditor training is desirable.
• Proficiency with standard computer software, especially Microsoft Office.

Required skills

• Knowledge of ISO 13485 quality management systems.
• Understanding of Good Manufacturing Practices (GMP) and FDA regulations.
• Competence in using Microsoft Office applications.