Manufacturing Process Specialist

hace 2 semanas


Ponce, Ponce, Puerto Rico Eqval A tiempo completo
Job Description:

We are seeking a highly motivated Manufacturing Process Specialist to support our New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment at Eqval Consulting Group, Inc.

Key Responsibilities:
  • Generate and execute validation protocols for new or replaced equipment, or process changes
  • Perform initial set-up, conduct and/or support troubleshooting, including continuous improvement, of production equipment and processes
  • Support investigations process (NCRs, Complaints) and teams with Manufacturing and QA personnel for review and disposition of investigations on time
Requirements:
  • Bachelor Degree in an Engineering Field
  • 3+ years of knowledge and experience in cGMP in a Medical Devices manufacturing environment
  • 3+ years of equipment qualification and process validation knowledge (IQ, OQ, PQ protocols generation and execution, deviations and reports generation)
  • 3+ years of statistical analysis (GR&R) and data management (including the usage of statistical tools, i.e, Minitab)
  • Knowledge and skills in diverse areas such as: Investigations (NCRs, Complaints, CAPA), Lean Manufacturing and Six Sigma Tools
  • Knowledge with pFMEA (analysis and development)
  • Highly Motivated, Self Starter and Multi Task Oriented
  • Computer literate (Word, Excel, Power Point, Minitab)
  • Excellent communicator (spoken, written) in both, English and Spanish
  • EIT or PE license
Estimated Salary:

$120,000 - $150,000 per year



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