Sr. Quality Engineer

Eqval Consulting Group, Inc.

  • Juncos, PR
  • Permanente
  • Tiempo completo
  • Hace 2 días
EQVAL Group, Inc. is a company that provides services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies, others). We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.We are seeking a Sr. Quality Engineer with at least four (4) years of experience in process validation, equipment qualification, and quality systems within regulated environments. The ideal candidate has hands-on experience with process validation (PV), computer system validation (CSV), nonconformance handling, CAPA, and root cause investigations, along with strong analytical, technical writing, and communication skills.Key Requirements:
  • Bachelor's Degree in Engineering (Mechanical, Electrical, or Chemical preferred)
Minimum of 4+ years of experience in:
  • Process Validation (PV: Characterization, OQ, PQ)
  • Equipment Qualification / Computer System Validation (CSV: URS, FAT, IQ, OQ, PQ, TMV)
  • Nonconformance (NC) investigations and CAPA management
  • Root cause analysis and problem-solving methodologies
  • Experience working in regulated environments (Medical Devices preferred)
  • Basic knowledge in validation strategies (requirements flow-down from design to manufacturing)
  • Experience with risk management documentation (pFMEA)
  • Basic knowledge of statistical techniques (preferably using Minitab)
  • Strong technical writing and documentation skills
  • Effective communication skills (English and Spanish)
  • Experience investigating manufacturing events to support product disposition
  • Experience analyzing and trending defects, yields, and rejects
  • Knowledge of Medical Device regulations (e.g., FDA, ISO)
  • Experience supporting and executing Design Transfer activities
Key Responsibilities:
  • Generate, execute, and review process validation protocols and reports (PV: Characterization, OQ, PQ)
  • Support equipment qualification and computer system validation activities (CSV: URS, FAT, IQ, OQ, PQ, TMV)
  • Lead and support nonconformance investigations, ensuring proper documentation and timely closure
  • Initiate, develop, and manage CAPAs, ensuring effectiveness and compliance
  • Perform root cause analysis using structured problem-solving methodologies
  • Define and support validation strategies, ensuring requirements traceability from design through manufacturing
  • Develop and maintain validation and quality documentation in compliance with regulatory requirements
  • Support risk management activities, including pFMEA development and updates
  • Analyze data using statistical tools to identify trends and drive continuous improvement
  • Coordinate activities with cross-functional teams, including engineering, operations, and quality
  • Ensure compliance with applicable federal and international regulations
  • Support design transfer activities and validation of manufacturing controls
  • Monitor and report status of validation and quality activities to ensure timely project completion
Benefits:
  • Dental insurance
  • Employee assistance program
  • Employee discount
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Professional development assistance
  • Referral program
  • Vision insurance
Work Location: In person

Buscojobs