ISO 13485 Compliance Specialist

Responsibilities

We are looking for a motivated and experienced Quality Engineer to join our team. As a Quality Engineer, you will be responsible for ensuring compliance of ISO 13485 and making sure appropriate metrics and key performance indicators are defined, measured, and analyzed.

• You will assist engineering in defining in-process inspection and incoming inspection requirements.
• Evaluate process critical quality parameters and update specifications and protocols.
• Work with different departments to find root cause analysis, corrective actions, and preventive measures.
• Make recommendations for replacing production equipment and monitoring devices before end of lifecycle.