Advertiser: Volpara Health Technologies LimitedMore jobs from this company
- Job Listing Date
- 8 Apr 2019
- Wellington, Wellington Central
- Work Type
- Full Time
- Science & Technology, Quality Assurance & Control
About the business
Volpara Health Technologies is a Medical Device Software company dedicated to saving families from breast cancer through the provision of outstanding software tools. We are certified to ISO 13485:2016 and ISO 27001:2013 and need to comply with regulatory obligations of the many countries we sell our products into, for example, those for CE Marking, MDSAP for USA, Canada, Japan and Australia and more.
About the role
As Quality Manager you will:
Have day-to-day responsibility for the quality management system (QMS): establishing, implementing and maintaining policies to ensure compliance with all necessary standards and Regulatory obligations across the whole of our global company, but mainly within engineering in Wellington.
Ensure that all necessary processes across the company are established, implemented, and maintained. All documentation/records are created and stored to ensure compliance and traceability as required.
Reporting to the COO/VP Regulatory, the role will also include assisting senior staff like the VP Engineering with the Product Development Manual.
The QM will prepare for and manage (if not lead) external quality audits, with support from the Regulatory Manager, CEO and others as necessary. Also, participate in other external audits, for example ISO 27001.
Have supervisory responsibility for the Quality Assistant whose main role is to ensure all internal audits are completed according to the established internal audit plan with findings reported and actioned in a timely fashion for all the standards we comply to.
Through discussion with relevant Teams heads establish yearly Quality Objectives. Actively monitor these Objectives and ensure steps are taken to enable the company to meet them.
Ensure that timely and effective corrective and preventative action is taken by all staff to ensure compliance with the QMS
Monitor the use of all external suppliers & distributors to ensure they are correctly evaluated, monitored and performing as per our requirements.
Liaise with CISO to ensure that where the Quality and Information Security standards /regulations overlap the associated policies work in harmony and do not conflict.
Report to top management through Management Review on the performance and effectiveness of the quality management system including any need for improvement.
Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
Skills and experience
You will be someone with:
Experience in Quality Management within a medical device company
Ideally, a background in software development
A strong sense of ownership and who proactively takes responsibility.
A willingness to provide direct feedback, suggest options to solve problems and to work with teams to improve and optimise their processes such that they are not an unnecessary burden on the company.
The ability to push back and argue your case if you don't agree with what's being done but also make considered decisions or come to sensible conclusions that provide the business with the best outcome.
Experience of building rapport with people at all levels within a company, both those who work in the office and those working remotely which might cover very technical to very commercial people.
- Which of the following statements best describes your right to work in New Zealand?
- How many years' experience do you have in a quality assurance (QA) role?
- What's your expected annual base salary?