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 experienceWorking knowledge of IQ / OQ / PQ, ISO standards, GMP guidelines, FDA regulations, and Lean methodologies preferredProficient in Microsoft Office; experience with Minitab, CAD software, and CMM equipment is a plusSolid understanding of blueprint reading and GD&T principlesStrong communication, organizational, and problem-solving abilities