Description:

SUMMARY
Manage and improve all processes with the WHK medical device manufacturing department. Work with Quality to ensure all systems are in compliance with ISO 13485. Implement new processes and assist with onboarding of all new business. Set-up and manage all BOMs and Routings in ERP system for new part introduction and for any process changes. Promote safety, housekeeping, and area improvement initiatives.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Candidate should possess previous experience in medical device manufacturing.
• Work with Quality to ensure that all processes are in compliance with ISO 13485 requirements.
• Write IQ/OQ/PQ validation protocols, execute validation protocols for new equipment and process changes, and write summary reports for management review and approval of all validations.
• Lead, participate, and...