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Group Quality Manager - Software and Informatics

About the role

 

If you’re looking for an opportunity to make an impact, this could be the role for you.

 

Supporting a range of internal customers, the Group Quality Manager for Software and Informatics leads a team of Quality Engineers as the subject matter expert and trusted advisor in quality management systems (QMS) for software development, Software as a Medical Device, and ICT systems in the medical devices industry.

 

Reporting to the GM of Group Quality, the role will develop strategies to guide the Informatics management team on best practices and approaches to complying with state-of-the-art standards for Software as a Medical Device and applying Agile Development Operations in a highly regulated environment.

 

It will also provide oversight and direction and serve as a subject matter expert to the ICT Leadership team on software validation and relevant compliance matters. More specifically, ensuring processes support mastering the art of designing computerised quality management systems to good engineering practices whilst remaining competitive with agile approaches.

 

With passion and initiative, The Group Quality Manager will lead change by influencing the organisation on all levels to develop and continuously improve ICT and Software development quality processes and compliance standards.

 

The role also leads a team of highly motivated and ambitious Quality Engineers who specialize in Commercial Off the Shelf Systems, Software Development, and Informatics.

 

 

Skills and Experience

 

We are looking for someone with: 

  • A Bachelors degree (at minimum) in engineering, science or clinical.
  • Manager/ Senior level experience in quality/ software development in the medical devices industry, including expert knowledge and experience in a range of quality processes.
  • An understanding of modern Dev Ops practices in a cloud-first software development program with globally deployed Software as a Medical Device product.
  • Expert knowledge and experience with Quality Management Systems related to software development, (such as GAMP 5, ISO3485, IEC 62304, AAMI TIR.57, 21 CFR 820, and EU MDR), including experience establishing a QMS.
  • Experience with development methodologies such as Waterfall, such as computerised system validation (CSV) or computerised systems assurance (CSA).
  • Experience with COTS, ‘Commercial Off the Shelf’ products.
  • Experience working with mobile platform and client portal-based products preferred.
  • Proven experience interpreting and complying with global medical device regulations, or knowledge of quality/ regulatory requirements for medical devices.

 

You will also have:

  • Experience partnering with a variety of customers across the business together with exceptional communication and influencing skills and the ability to listen to customer needs and to empathise and understand requirements.
  • Demonstrated leadership experience working with and leading a team of engineers who will look to you for leadership and professional development.

 

 

 

 

 

Benefits

 

  • Employee share purchase scheme
  • Bi-annual Profit share
  • Generous paid Parental Leave
  • Life, Critical illness and Income Protection Insurance
  • Discounted Health Insurance
  • Active Social clubs and community groups
  • In-house training programs from external providers
  • Purchasing privileges for Fisher & Paykel Healthcare products
  • School holiday programme subsidy
  • Banking and Insurance discounts
  • Free Parking
  • Beautiful campus with green spaces including EV charging stations and end of trip facilities to encourage lower-impact transport choices
  • Subsidised Café’s
  • Annual Salary Review
  • High rates of internal promotion

 

 

About Us

 

Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally. We are an iconic New Zealand company with a consistent growth strategy ensuring an expanding range of innovative devices for use in respiratory care, acute care and the treatment of obstructive sleep apnea.

 

We focus on nurturing a positive and inclusive culture based on trust and respect. In New Zealand, our employee-led communities, Spectra (rainbow), Manaaki (Māori) and Women in Engineering play an important role in this culture. We also have a commitment to creating a positive lasting impact on society, shown by our support of New Zealand organisations such as Diversity Works NZ, Pride Pledge and Global Women.

 

If you're seeking a role with endless opportunities to develop, grow and advance your career, then apply now!

 

We are dedicated to designing our recruitment process with care and empathy to support all candidates, regardless of identity, background, and experiences. Should you require support or adjustments during our process, please let us know at recruit@fphcare.co.nz.

 

 

Requisition ID: 3327 
Posting end date: ​31/12/2023

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