Medical Device Validation Engineer

hace 1 día


Añasco, Puerto Rico Labchems Corp. A tiempo completo

Job Overview

Labchems Corp. is seeking a highly skilled Medical Device Validation Engineer to support the European Union Medical Device Regulation (EU MDR) program.

About the Role

The successful candidate will participate in data gathering, gap assessments, remediation planning, and documentation generation and execution for EU MDR compliance.

Key Responsibilities

  • Data Gathering–Participate in the discovery and compilation of required documentation to be evaluated.
  • Gap Assessments–Assess all manufacturing documentation such as product device master record, process flow charts, incoming inspections, final inspections, validation plans and process validations.
  • Remediation Plan–Generate and execute validation documentation (change control, validation plans, validation protocols, validation closure reports, technical reports / memos) and update manufacturing documentation.

Requirements

• BS in Science or Engineering (Mech, Ind, Elec, Chem, or Biomedical)
• MUST HAVE KNOWLEDGE OF EUROPEAN UNION MEDICAL DEVICE REGULATION (EU MDR 2017/745), European Union Medical Device Directive 2007/47/EC and ISO13485:2016 Medical Devices–Quality Management Systems.
• Hands-on experience with EU MDR or MDD remediation projects, compliance projects and process validation are required.
• Minimum of 5 – 7 years of experience in the medical device and/or pharmaceutical manufacturing; with at least five (5) years in manufacturing process, quality or validation engineering position and preferably with exposure to Packaging Validations, Design Control and Product/Process Transfer.
• Proficient with Minitab for advanced statistical analysis.
• Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.



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