Quality Assurance and Validation Lead

hace 21 horas


Añasco, Puerto Rico Labchems Corp. A tiempo completo

Job Requirements

We are seeking an experienced Quality Assurance and Validation Lead to join our team. The successful candidate will be responsible for ensuring the quality and integrity of our products and processes.

About the Role

The Quality Assurance and Validation Lead will be responsible for:

  • Supporting the development and implementation of quality and validation policies and procedures.
  • Participating in data gathering, gap assessments, and remediation planning to ensure compliance with EU MDR regulations.
  • Developing and maintaining technical documentation, including change controls, validation plans, and validation protocols.

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.
• 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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