Senior Design Transfer Quality Engineer

Senior Design Transfer Quality Engineer

 

About the role

This position is the primary Manufacturing Quality Assurance resource to product design teams, production support staff and stakeholders for problem identification, resolution, loss reporting, design reviews, and continuous improvement initiatives. You will be working in partnership with the Design team, Manufacturing and Engineering and being responsible for ensuring that products are manufactured in accordance with company requirements and FDA/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. 

 

Responsibilities

  • Develop, apply and maintain quality requirements and standards for development and manufacturing products.
  • Support concurrent engineering efforts by participating in design development projects representing Quality Assurance.
  • Design and implement methods for process control, process improvement, testing and inspection.
  • Promote and execute quality standards, inspection processes, test methodology, quality plans, documents and reports.
  • Leads and participates in FMEAs (Failure Mode Effect & Analysis) for design and process.
  • Develop, execute and analyze quality-reporting measures. Perform RCA (Root Cause Analysis).

 

Skills and Experience

  • Science or engineering tertiary degree
  • Minimum 5 years related experience in the medical device industry
  • Having experience in Design Quality Engineering and Transfer of product to manufacturing
  • Diverse knowledge of inspection and control methods, techniques and documentation.
  • Understanding of FDA and ISO 13485
  • Verification and process validation experience
  • Exposure to statistical analysis techniques
  • Excellent communication and influencing skills
  • Ability to build strong relationships at all levels within the organisation
  • Experience in DFMEA, 8D, DFM.
  • Familiarity with Regulatory Requirement

 

About the company

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.