Molding Validation Engineer

Experience 
5–7 years minimum in MedTech or regulated manufacturing environments

Required Qualifications
Bachelor’s degree in Engineering (Mechanical, Biomedical, Polymer/Plastics, Industrial, or related field). 
5–7 years of hands-on experience in *plastic molding validation* within MedTech, Pharma, or regulated manufacturing industries. 
Strong knowledge of *IQ/OQ/PQ protocols, SAT/FAT execution, and equipment qualification*. 
Proficiency in *Minitab* and statistical tools for process validation and capability analysis. 
Demonstrated experience in *CAPA management* and root cause analysis methodologies. 
Familiarity with *FDA QSR, ISO 13485, EU MDR, and GMP requirements*. 
Excellent technical writing and documentation skills. 
Strong communication and stakeholder management abilities.