Senior Design Transfer Quality Engineer

About the role 

As a Senior Design Transfer Quality Engineer you will be the primary Manufacturing Quality Assurance resource working together with our  Product design, Process development teams, and stakeholders on problem identification, resolution, design reviews, and continuous improvement initiatives. You will be working in partnership with the Design, Manufacturing and Engineering teams and being responsible for ensuring that new manufacturing processes are designed and developed in accordance with company requirements and FDA/ ISO-13485 regulations, as well as all applicable international regulatory requirements. As this is a Senior position your experience within the medical device industry will add value to this role and allow you to influence and mentor junior members of the team.  

Skills and Experience 

• Minimum 5 years related experience in the medical device industry 

• Having experience in Design or Manufacturing Quality Engineering and Transfer of product to manufacturing 

• Diverse knowledge of inspection and control methods, techniques and documentation. 

• Understanding of FDA , ISO 13485 and ISO 14971 

• Process verification and validation experience 

• Exposure to statistical analysis techniques 

• Excellent communication and influencing skill 

• Ability to build strong relationships at all levels within the organisation 

• Experience in DFMEA, PFMEA, 8D, DFM. 

• Familiarity with Regulatory Requirement 

• Science or engineering tertiary degree 

About the company & culture 

We are a world leader in the delivery of medical devices for use in respiratory and acute care and in the treatment of obstructive sleep apnoea. We are inspired by providing solutions that improve the care and outcomes for our customers and their families and ultimately the wider global healthcare system. We are listed on the NZ and Australian stock exchanges, we have sales people in over 40 countries, distribute our products in over 120 countries and employ over 6000 people globally. Working with us means being part of a diverse team cultivating a culture that empowers individuals to share ideas and experiences to make the right choice for our patients.