Description

You will own manufacturing process development and continuous improvement for medical devices.

This role is on-site.

Responsibilities

• Develop, validate, and improve manufacturing processes and equipment, including IQ/OQ/PQ.
• Troubleshoot and resolve process and quality issues directly on the production floor.
• Lead root cause investigations and implement corrective and preventive actions.
• Partner with Quality, R&D, and Operations to support design transfer and new product builds.
• Maintain accurate documentation, including DHRs, BOMs, and process instructions.

Required Skills

• 9+ years of medical device manufacturing experience.
• Strong understanding of GMP, FDA 21 CFR 820, and ISO 13485 requirements.
• Experience with QMS, DHR, and BOM documentation.
• Proven ability to solve complex process problems.
• Experience operating within ISO 13485 environments.
• Bachelor's degree.

Key Skills

Education

Bachelor's degree