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Quality/Labeling Consultant

Job Description

Title: Quality/Labelling Consultant

Location: Onsite in Thousand Oaks, CA

Duration: 5 months, high likelihood of extension

About the Company:

Join my Client's enthusiastic and motivated quality/regulatory team and be the leader of a quality/labelling remediation project. This person will be responsible for getting their labelling process compliant to ISO 13485:2016 and MDSAP standards. They will have an audit later this year, and this person will be responsible for the labelling being compliant.

The Role:

There is one consulting position available supporting the quality/regulatory team, and reporting to the Sr. Manager of Quality Systems, and VP of Quality/Regulatory.

Responsibilities:

  • Effectively designs labelling program.
  • Responsible for labelling/training effectiveness.
  • Will train other staff members on labelling process and updates.
  • Will be responsible for passing third party audits in association with MDSAP and ISO 13485:2016 regulations.
  • Performs quality control checks.
  • Responsible for maintaining excellent working knowledge of labelling process from start to finish.
  • Designs experiments and assists with validation studies for new or modified products, processes and system software in regards to labelling program
  • Identify and implement process improvements.
  • Assist in 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.

Qualifications:

  • At least 5 years of experience in implementing quality systems and process improvements during the development, manufacture, and commercialization of medical device or pharmaceutical products.
  • Experience with the development of labelling processes that address ISO 13485:2016 requirements.
  • Knowledge in FDA and ISO regulations and guidance documents
  • Project management
  • Problem recognition, analysis and recovery
  • 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.