Demo

Quality Engineer

Cynet Systems
San Diego, CA Full Time
POSTED ON 3/1/2025
AVAILABLE BEFORE 5/26/2025

Job Description :

Pay Range : $43hr - $48hr

Responsibilities :

  • Perform equipment and process validation, including writing / reviewing protocols, reports, data analysis, and managing deviations for new, existing, and relocated activities.

Equipment Maintenance :

  • Support medical device or biological equipment maintenance from a quality standpoint, including preventive maintenance, calibration, and Out of Tolerance activities.
  • Qualification Execution :

  • uthor and execute Installation, Operational, and Performance Qualifications (IQ, OQ, PQ) for analytical and manufacturing equipment.
  • GMP Equipment Validation :

  • Execute validation and qualification of GMP equipment and functions throughout the manufacturing facility.
  • Risk Management Documentation :

  • Review and update FMEA or Risk documents as necessary to support validation activities.
  • Manufacturing Process Relocation :

  • Perform additional duties to ensure business continuity during process relocations, including executing QA inspections and reviewing and approving documents like batch records to support finished product release.
  • Education and Experience :

  • BS in Biological Sciences, Chemistry, Bio-Tech Engineering, Bio-Engineering, or a related field.
  • Minimum of 3-5 years of experience in the Medical Device, Biotech, or Pharma industry.
  • Senior QE : Minimum of 5-7 years of experience in the same industries.
  • Quality Systems :

  • Knowledge of quality system methodologies and regulations.
  • Statistical Analysis :

  • Basic statistical analysis knowledge (e.g., Minitab, Excel).
  • Validation Knowledge :

  • Strong knowledge of process validation and equipment validation.
  • ISO Standards :

  • Strong understanding of ISO 9001, ISO 14971, and ISO 13485 (Design Control, Supplier Management, and Risk Management).
  • Six Sigma :

  • Hands-on experience with Six Sigma methodologies.
  • SAP Knowledge :

  • Proficiency in SAP.
  • Equipment Management System :

  • Familiarity with equipment management systems such as BMRAM (preferred).
  • Salary : $43 - $48

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