Description

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

Responsibilities

• Develop, validate, and improve manufacturing processes and equipment (IQ/OQ/PQ).
• Troubleshoot and resolve process and quality issues directly on the production floor.
• Lead root cause investigations and implement corrective/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

• 7+ years of medical device manufacturing experience.
• Strong understanding of GMP, FDA 21 CFR 820, and ISO 13485 requirements.
• Experience with Qms, Dhr, and Bom’s documentation.
• Proven ability to solve complex process problems.
• Experience operating within ISO 13485 environments.

Key Skills

Education

Bachelor's degree