Quality Engineer
millenniumsoft - San Diego, CA
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Roles & ResponsibilitiesConduct equipment and process validation, including protocols, reports, and data analysis.Maintain and support equipment validation, calibration, and preventive maintenance.Execute IQ, OQ, PQ for manufacturing equipment.Update FMEA and risk documents as needed.Support QA inspections and document approvals during process relocations.Experience RequiredFor QE II: 3-5 years in Medical Device, Biotech, or Pharma industries.For Sr. QE: 5-7 years in similar fields.Skills & CertificationsStrong verbal and written communication, including technical document writing.Knowledge of quality systems and methodologies.Basic statistical analysis skills (e.g., Minitab or Excel).In-depth knowledge of process and equipment validation.Experience with Six Sigma methodology.Familiarity with SAP and equipment management systems like BMRAM.Ability to work both independently and collaboratively with minimal supervision.Organizational skills and multitasking abilities.Eligibilities & qualificationsBS in Biological Sciences, Chemistry, Bio-tech Engineering, Bio-engineering, or related fields.
Created: 2026-04-02