Senior Quality Engineer – Process & Validation Leader
jabil
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Job summary
Jabil in Mexico is seeking a senior Quality Operations leader to guide the Workcell QA/NPI team, implement quality plans, and ensure product conformance to ISO 9001/13485 and CFR 21 Part 820. You will lead the development and maintenance of inspection methods and validation activities, and drive data-driven decisions across manufacturing.
Interfaces with manufacturing, engineering, customers, vendors and subcontractors to meet requirements; administer CAPAs, audits, and quality systems, and
Qualifications
- Proficiency with PC and MS Office (Excel, Word, PowerPoint)
- ASQ CQE certification preferred
- Regulated Quality System knowledge (ISO 13485/9001)
- English proficiency (intermediate-advanced) mandatory
- Experience in quality control, inspection, and data analysis
Responsibilities
- Develop, modify, and maintain quality plans and control protocols
- Create and validate inspection methods and equipment evaluation
- Support quoting during early design stages
- Lead quality operation activities for product release
- Approve batch records and revise manufacturing processes
- Own validation activities and approval processes
- Support software validation for Quality System tools
- Ensure CAPA processes meet ISO and CFR requirements
- Lead quality audits and supplier/third-party oversight
- Mentor Inspectors and Technicians and manage direct reports
Skills
Education
Tools
Job description
Jabil in Mexico is seeking a senior Quality Operations leader to guide the Workcell QA/NPI team, implement quality plans, and ensure product conformance to ISO 9001/13485 and CFR 21 Part 820. You will lead the development and maintenance of inspection methods and validation activities, and drive data-driven decisions across manufacturing.
Interfaces with manufacturing, engineering, customers, vendors and subcontractors to meet requirements; administer CAPAs, audits, and quality systems, and
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