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Process Engineering Auditor
2 months ago
Position: Process Engineering Auditor - Med Device
Location: Ventura, CA
Start Date: ASAP
Duration: 12+ month contract
Summary
As a Process Engineering Auditor, you will play a critical role in optimizing, scaling up & troubleshooting manufacturing processes for the production of medical device products.
Qualifications:
- B.S. in mechanical engineering, or a related field
- At least 1 years’ experience in med device process development and manufacturing
- Knowledge of regulatory requirements for med device manufacturing
- Experience in process trouble shooting
- Hands on experience in validation within med device
- Solid project management experience with a demonstrated ability to plan, execute and oversee cross-functional projects
Responsibilities:
- Continuously evaluate and improve medical device manufacturing processes to enhance efficiency, yield, and product quality.
- Develop, implement, and analyze process validation studies to ensure robust, well-controlled processes.
- Provide technical expertise and support to manufacturing teams for the resolution of process-related issues & deviations.
- Maintain detailed process documentation, standard operating procedures (SOPs) and batch records.
- Collect and analyze data, including process data, to identify trends, root causes, and areas for improvement.
- Ensure manufacturing processes comply with regulatory requirements, industry standards and company policies.