JT880 - SR. MANUFACTURING ENGINEER

Quality Consulting GroupJuncos, PR
5d

About The Position

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Requirements

  • Bachelor's degree in engineering
  • 4+ years of experience in related area
  • Change control of Medical Devices
  • Equipment Commissioning / Qualification
  • Process Validation 4. Computer System Validation (CSV)
  • Manufacturing, Packaging and Laboratory Equipment
  • Technical experience (Trouble shooting) or any similar experience or background
  • Quality / Process Control / Assurance of Medical Devices
  • Process Validation and Computer software validation knowledge.
  • Equipment Validations Manage Supplier Change Requests
  • Advise Project Lead
  • Mechanical technical lead
  • Manufacturing Documentation
  • Availability for 1st shift

Responsibilities

  • Execute equipment & test method validations, preform manufacturing procedure changes.
  • Coaches and reviews the work of lower-level specialists; may manage projects / processes.
  • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
  • Ensures processes and procedures are in compliance with regulations.
  • Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
  • Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
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