Quality Engineer II – Process & Quality

About the role

We are looking for a Process / Quality Engineer to join our manufacturing and new product development teams. In this role you will ensure that our medical‑device products meet the highest quality standards while driving continuous improvement across processes.

Key responsibilities

• Identify and resolve manufacturing defects, non‑conforming materials and customer complaints.
• Lead root‑cause investigations and implement corrective and preventive actions (CAPAs).
• Support product quality plans by reviewing specifications, procedures and quality systems.
• Monitor and improve processes to reduce variation and increase efficiency.
• Analyze quality metrics to identify trends and improvement opportunities.
• Support new product introduction and ensure smooth transfer to manufacturing.
• Participate in process and equipment validations (IQ/OQ/PQ).
• Review and interpret technical documents, drawings and protocols.
• Collaborate with Manufacturing, R&D and Suppliers.
• Ensure compliance with ISO standards, cGMPs and internal procedures.
• Assist in supplier quality activities, including sampling plans and inspections.

Required profile

• Bachelor’s degree in Engineering (Industrial, Mechanical, Electromechanical or related).
• 6+ years of experience in manufacturing or supplier quality engineering.
• Experience in the medical‑device industry is preferred.
• Experience supporting new product development is a plus.

Required skills

• Knowledge of ISO standards and cGMP requirements.
• CAPA management and root‑cause analysis.
• Process validation (IQ, OQ, PQ).
• Quality metrics analysis.
• Technical document and drawing review.
• Supplier quality activities (sampling plans, inspections).