Supports manufacturing quality and process validation in a highly regulated environment through risk management, documentation review, and process capability assessments.

Job Responsibilities:

Review engineering drawings and specifications for accuracy and compliance

Evaluate and approve Manufacturing Process Control Plans

Conduct reviews of Measurement System Analysis (MSA) and Test Method Validation (TMV)

Perform assessments of manufacturing process capabilities

Review and support manufacturing process validation activities

Participate in risk management activities specific to medical device manufacturing

Job Requirements:

Bachelor