Katalyst CRO
Sr. Quality Ops Engineer
Katalyst CRO - San Jose, California, United States, 95199
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Sr. Quality Ops Engineer
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Katalyst CRO . Looking for a senior operations quality engineer for six months starting from June. The role involves supporting the current senior engineer on a product transfer project, including: Reviewing risk management files (pFMEA). Reviewing process validation protocols and reports. Drafting/updating the master validation plan. Reviewing manufacturing process instructions. Drafting quality inspection procedures. Reviewing equipment introduction, calibration, and PM records. Responsibilities
Support the product transfer project by performing the above tasks and ensuring compliance with quality standards. Requirements
Bachelor's degree in engineering (Mechanical, Biomedical, Industrial, or related) or equivalent experience. 5+ years of quality engineering experience in a medical device manufacturing environment (Class II preferred). Strong knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, and ISO 14644. Experience with CAPA, NCMR investigations, root cause analysis, and SPC. Proficiency in Process Validation, Gage R&R, and AQL sampling plans. Ability to interpret engineering drawings, GD&T, and work with metrology tools. Prior experience with BMRAM and Propel is a plus. Additional Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Quality Assurance Industry: Pharmaceutical Manufacturing
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Sr. Quality Ops Engineer
role at
Katalyst CRO . Looking for a senior operations quality engineer for six months starting from June. The role involves supporting the current senior engineer on a product transfer project, including: Reviewing risk management files (pFMEA). Reviewing process validation protocols and reports. Drafting/updating the master validation plan. Reviewing manufacturing process instructions. Drafting quality inspection procedures. Reviewing equipment introduction, calibration, and PM records. Responsibilities
Support the product transfer project by performing the above tasks and ensuring compliance with quality standards. Requirements
Bachelor's degree in engineering (Mechanical, Biomedical, Industrial, or related) or equivalent experience. 5+ years of quality engineering experience in a medical device manufacturing environment (Class II preferred). Strong knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, and ISO 14644. Experience with CAPA, NCMR investigations, root cause analysis, and SPC. Proficiency in Process Validation, Gage R&R, and AQL sampling plans. Ability to interpret engineering drawings, GD&T, and work with metrology tools. Prior experience with BMRAM and Propel is a plus. Additional Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Quality Assurance Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr