JCW Group
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