Junior Quality System Specialist

Here at Volpara, we’re on a mission to prevent advanced-stage cancer. By combining our ground-breaking Breast Health Platform with empowered patients, we are unleashing a revolution in cancer detection. 

The Junior Quality System Specialist will be responsible for the day-day operational aspects of Volpara’s medical device quality management system - helping ensure our software is safe for the patients who our customers screen and treat and passes all our external medical device audits. This role also plays a critical role in helping our employees understand and have a positive attitude to our quality management system.

What you will be doing

• Manage day-day quality teams specific processes including document management, quality events, suppliers, corrective actions, software validation, change requests.


• Contribute to internal and external audit programs.


• Track and report on service incidents and key performance indicator trends and identifying areas for improvement.


• Prepare product quarterly performance trend reports based on defects, incidents, complaints and KPIs and any emerging safety risks, required to meet regulatory requirements.


• Create post market surveillance reports required to meet regulatory requirements.


• Support the operation of the Quality Management System tooling, including training of employees on its use.


• Create, maintain, and promote a quality knowledgebase that educates employees on quality system concepts and its operation, through running regular training sessions and internal communication platforms.


• Perform other duties as requested from time to time.

What you will bring to the role

• Tertiary qualification in an engineering or science related subject required.


• People oriented; clear and concise verbal and written communication.


• Knowledge of statistical techniques preferred.


• Experience of quality management system requirements such as ISO 9001 or ISO 13485 preferred.


• Knowledge of regulatory requirements such as MedSafe or FDA preferred.


• Knowledge of software product development preferred.
  


• Experience with internal auditing desired but not essential. 

NB: If you're within reasonable commuting distance to our Wellington office, you're required to come into the office at least on Thursdays. 

Volpara Health is an Equal Employment Opportunity employer. We will endeavor to fill vacancies with the candidate who is the best fit for the role, without regard to gender, marital or family status, religious or ethical belief, race, ethnic or national origin, disability, age, political opinion, employment status, sexual orientation or any other status protected by law.