Quality Systems Manager
About the company
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 are seeking a Group Quality Manager to join our Group Quality team who is passionate about contributing to a company focused on growth and making a difference to improve patient care and outcomes.
About the role
Being part of our Group Quality team, you will be the subject matter expert and trusted advisor in quality management systems for software development, Software as a Medical Device and ICT systems in the highly regulated medical device industry. You will establish and deploy global quality system processes that add value, meet internal customer expectations, and enable the product development teams comply with international regulations and standards. You will serve as a trusted advisor to the Informatics Research 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 to a high regulated medical device environment. You will also serve as a trusted advisor and SME to the ICT department leadership on how to deploy enterprise systems as a part of a digital transformation effort for the organization. With your passion and initiative, you will lead change by influencing the organization on all levels to develop and continuously improve ICT and Software development quality systems to support our teams. You will also be charged with the growth and development of a team of Quality Systems Engineers who specialize in both respective areas under your purview. This is a highly motivated and ambitious team and their professional development will depend strongly on your leadership skills.
Skills and Experience
- Engineering or relevant tertiary qualification
- 5 years in quality/development in a highly regulated industry
- Expert knowledge and experience with Quality Management Systems related to software development, such as GAMP 5, IEC 62304, AAMI TIR.57, 21 CFR 820, and EU MDR
- Exceptional communication and influencing skills
- Understanding of modern Dev Ops practices in a cloud-first software development program with globally deployed Software as a Medical Device product
- Experience working with mobile platform and client portal based products preferred
- Experience advising leadership on digital transformations throughout a global organization is strongly preferred
- Demonstrated knowledge of quality/regulatory requirements for medical devices preferred
- Enjoy working with and leading a team of junior engineers who will look to you for leadership and professional development
Company and Culture
Our company recognizes that innovation is a key ingredient to sustained growth and profitability. You will reap the rewards of working for an organisation that is focused on growing internationally and acknowledges their people through a comprehensive range of benefits, career opportunities and a great working environment.
If you are looking to build on your career, this could be the opportunity you have been looking for! Don't miss out on this great opportunity. Apply now!