Process Quality Engineer

What you'll do

• Lead and ensure the quality of NPI and manufacturing processes.
• Lead and support Process Validation activities (IQ/OQ/PQ).
• Review and approve work instructions, assembly instructions, manufacturing specifications, validation protocols, validation reports, as well as mechanical part and assembly drawings created in SolidWorks.
• Support and manage Change Control processes.
• Provide professional guidance to R&D, Engineering, and Manufacturing teams on quality requirements, NPI, and manufacturing processes.
• Collaborate closely with R&D, Engineering, and Manufacturing teams to implement process changes, drive continuous improvements, and ensure product quality.
• Identify, lead, and implement continuous improvements in NPI and manufacturing processes while ensuring compliance with quality requirements, ISO 13485 standards, and FDA regulatory requirements.
• Provide QA oversight and support for Design Transfer / NPI activities, ensuring a smooth and compliant transfer of products from R&D to manufacturing.
• Reports to
• QA Manager