Quality Lead, Newmarket, Auckland
Full time
at Obex Medical Limited
in
New Zealand
Posted on May 8, 2024
Job details
- We are proudly a certified Great Place to Work company
- Role with direct impact on NZ healthcare
- Training and development support within highly professional team
- Provide regulatory leadership to ensure adherence to compliance related standards and the smooth running of regulatory activities
- Work with sales and marketing team to advance Supplier relationships and continue to grow Obex regulatory reputation in market
- Ensure compliance with NZ sponsor responsibilities for medical devices and medicines
- Coordinate the administration of Promapp to optimise the functionality and to ensure robust company processes
- Manage the pharmacovigilance process and MOH audits as required. Coordinate new and existing staff training in pharmacovigilance
- Manage the renewal of dangerous goods safety datasheets with external consultant
- Manage the ISO Quality systems to ensure continued compliance with ISO9001 and ISO45001 standards
- Understanding of NZ device regulatory environment
- Experience training or coaching team members
- Understanding and experience in ISO and quality systems
- Experience using Promapp (or similar process mapping tool)
- Familiarity with regulatory frameworks
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