Description

You will develop, maintain, and apply quality evaluation systems and procedures for material processing and finished product manufacturing.

Responsibilities

• Lead and participate in project teams to implement manufacturing process improvements and continuous improvement initiatives.
• Execute validation projects and equipment validation in compliance with FDA requirements for medical device products.
• Manage CAPAs from assignment to closure, ensuring effective corrective actions and root cause analysis.
• Develop and revise Quality Plans, including incoming, in-process, and final inspection protocols.
• Oversee the change management program by performing technical reviews and risk assessments of requested changes.
• Perform technical reviews of data, write technical reports, and revise Standard Operating Procedures (SOPs).

Required Skills

• 7+ years of experience in quality engineering.
• Bachelor's Degree.
• Proficiency with Six Sigma tools.
• Experience with FMEA (Failure Mode and Effects Analysis).
• Expertise in DOE (Design of Experiments).
• Experience with MSA (Measurement Systems Analysis).
• Knowledge of CGMP (Current Good Manufacturing Practices).
• Application of CE Diagram and CE Matrix.
• Ability to manage nonconformance reports, FIRs, and MRB processes.

Key Skills

Education

Bachelor's Degree