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Part Time Quality Consultant

Job Description

Title: Quality Systems Consultant

Location: Onsite in Irvine, CA

Duration: 6 Months-Part Time

About the Company:

Join this diagnostic focused biotech in Irvine, CA. This Consultant will be helping this company with their ISO 13485:2016 updates. He/She delegate's tasks appropriately and also be doing much of the technical work. This person must be able to own their decisions, and be able to do the documentation. In addition, this consultant will be working directly with the CEO.

The Role:

There is one Part time consultant position available supporting the CEO with Quality needs.

Responsibilities:

  • Develop QC test procedures for work-in-process and finished goods.
  • Be an active team member in teams responsible for design control and conformance to FDA and ISO 13485 standards.
  • Develops quality and reliability plans for products including developing, conducting and implementing test protocols.
  • Designs experiments and assists with validation studies for new or modified products, processes and system software
  • Identify and implement process improvements.
  • Assist in supplier and internal audits.
  • Actively manages and implements corrective action functions through effective technical root cause failure analysis and troubleshooting investigations in resolving and precluding product, service and system failures and inefficiencies.
  • Mentor other engineers within the organization.
  • Other duties may be assigned, as needed.

Skills:

  • At least 10 years of experience in implementing quality systems and process improvements during the development, manufacture, and commercialization of point-of-care, in-vitro diagnostic platforms. Medical device or pharmaceutical industries is acceptable.
  • Experience with the development of point-of-care, in-vitro diagnostic platforms that address ISO 13485 design control requirements.
  • Knowledge in FDA and ISO regulations and guidance documents
  • Project management
  • Problem recognition, analysis and recovery
  • Reading and math
  • Group speaking
  • Computer literate; use of word processing, spreadsheets and data analysis software
  • Strong interpersonal skills with the ability to elicit the support and cooperation of others

Sthree US is acting as an Employment Business in relation to this vacancy.

Sthree US is acting as an Employment Business in relation to this vacancy.