Job Description

This position supports the Quality Engineering team through involvement in inspections, validations (IQ/OQ/PQ), documentation updates, and continuous process improvement efforts. Key duties include interpreting blueprints and GD&T, assisting in quality plan creation, and aiding in root cause analysis and complaint handling.

Key Responsibilities:

• Collaborate with quality engineers on product and process investigations, including complaint resolution
• Assist in the development of inspection and test methods, as well as execution of related protocols
• Support equipment qualifications, risk assessments, and manufacturing transfer activities
• Prepare and revise documentation such as work instructions and training content
• Maintain compliance with GMP standards, ISO13485 requirements, and FDA regulations

Qualifications:

• High school diploma with relevant technical training or equivalent work experience
• Working knowledge of IQ/OQ/PQ, ISO standards, GMP guidelines, FDA regulations, and Lean methodologies preferred
• Proficient in Microsoft Office; experience with Minitab, CAD software, and CMM equipment is a plus
• Solid understanding of blueprint reading and GD&T principles
• Strong communication, organizational, and problem-solving abilities

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