Process Manager - Design Controls
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 Quality Process Manager to join our Global Quality Systems 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 Global Quality Systems team, you will be the subject matter expert and trusted advisor in quality management systems focused on Design Controls and Risk Management in the highly regulated medical device industry. You will establish global quality system processes that add value, meet internal customer expectations and comply with international regulations and standards. With your passion and initiative, you will lead change by influencing the organization on all levels to develop and continuously improve global quality systems to support our teams.
Skills and Experience
- Engineering or relevant tertiary qualification
- Demonstrated knowledge of quality/regulatory requirements for medical devices
- 4-6 years in quality/development role in highly regulated industry
- Expert knowledge and experience with Quality Management Systems, especially focused on ISO 13485, FDA's Quality System Regulations and the Medical Device Single Audit Program
- Exceptional communication and influencing skills
- Project Management skills
- Analytical thinker
- Enjoy working autonomously as well as part of a high functioning team
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!