Quality Engineer
Validation & Engineering Group, Inc
Humacao, Puerto Rico
hace 33 días

Company Description

Validation & Engineering Group, Inc. is a leading service supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas : Compliance, Quality, Engineering, Validation, Project Management, among other services in Puerto Rico and USA.

Job Description

Main : Support Facilities, Utilities and Maintenance operations

  • Execute and conduct risk assessments.
  • Identify risk and ensure High and Critical Risks are communicated following procedures
  • Participate and lead mitigation initiatives.
  • Develop and maintain effective communication with the Risk Lead to ensure any deviation to the procedures are managed correctly.
  • Support the risk assessment documentation.
  • Provide expertise and recommendations in the selection of assessment methods.
  • Knowledge and experience with 21 CFR 4, 21CFR Part 820, EN ISO 14971, MDD 93 / 42 / EEC requirements.
  • Knowledge and experience with ISO 14971, ICH Q9 and 93 / 42 / EEC a PLUS!!!
  • Failure Mode and Effects Analysis, Preliminary Hazard Analysis, Hazard Analysis
  • Qualifications

  • Bachelor’s degree in Engineering (chemical, mechanical, industrial, electrical)
  • Minimum of 10 years of directly related experience (only resources with experience in the Biotechnology, Medical Devices and Pharmaceutical industries will be considered).
  • Familiar with the following standards : US Good Manufacturing Practices 21CFR820, cGMPs for Combination Products 21 CRF 4, Quality Management ISO 13845, EU Medical Device requirements Council Directive 93 / 42 / EEC, Medical Electrical Equipment EN 60601, Medical Device -
  • Software Life Cycle Processes - IEC / EN 62304 ( a Plus).

  • Failure Mode and Effects Analysis ( FMEA), Preliminary Hazard Analysis, and Hazard Analysis.
  • Strong Project management skills.
  • Excellent Technical writing skills.
  • Strong organizational skills.
  • Strong knowledge of and experience with processes involved in manufacturing and distribution.
  • Demonstrate ability to interact with all level of the organization.
  • Strong communication (both written and oral), facilitation and presentation skills.
  • Ability to evaluate compliance issues.
  • Available to work non-standard shifts requested and travel.
  • Bilingual (Spanish & English).
  • Additional Information

    Validation and Engineering Group, USA, Inc is an Equal Employment Opportunity employer.

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