Senior Quality Assurance Manager

The Role

The role is to lead IDE’s Quality and Capabilities group. Uniquely the role combines traditional aspects of quality assurance within a regulated environment with the development and continual improvement of the company’s capabilities in all aspects of design, product development, innovation, and entrepreneurship.  The purpose of the role is to merge and champion both these aspects of Quality throughout the organisation and work is executed with a high degree of technical excellence for IDE and its Clients through the following responsibilities -

Quality Management

  • Champion Quality at IDE by leading and continually improving IDE’s ISO 13485:2016 certified and ISO 9001:2015 & 21CFR820 compliant quality management system.

  • Manage and mentor a team of Quality Associates.

  • Represent IDE in audits from Clients, Regulatory Authorities and Accreditation Bodies.

  • Support the Design and Entrepreneurship function to carry out its objective of winning new Clients, Customers and revenue from the creation of new business opportunities.

  • Support the Product Development and Manufacturing Functions to efficiently maintain compliance and consistently produce high quality outcomes for Clients.

Capability management

  • Work with Management and Group Leaders to identify areas for improvement and growth pertaining to IDE’s capabilities.

  • Continually improve IDE’s capabilities by planning, budgeting and executing projects that support IDE’s mission.

 

Desired Skills and Experience

  • Strong interpersonal and communication skills

  • Coaching/mentoring skills and an ability to inspire the team to achieve objectives

  • An ability to work within the management team to develop company goals and translate them into planned and budgeted QACA activities to support the company in achieving its goals. A degree in Mechanical, Mechatronics or Biomedical Engineering, Industrial Design or similar applicable technical discipline.

  • Attention to detail, and a passion for efficiency and technical quality in design, development and manufacturing documents.

  • A demonstrated understanding of ISO 13485 or ISO 9001.

  • Experience in implementing Good Manufacturing Practice principles and a good understanding of 21CFR820.

  • Experience in undertaking internal and supplier audits.

  • A demonstrated ability to effectively train people on quality management principles and on how to comply with quality management systems.

  • Experience in undertaken risk management and risk analysis activities, including Hazards Analysis and FMEA.

  • Experience collaborating on design problems within a multi‐disciplinary R&D environment.

  • Ability to communicate a system engineering thinking approach from requirements through to execution.

  • Experience in undertaking manufacturing planning, quality control and process validation in medical device manufacturing environments.

  • An understanding of Medical Device Regulatory Affairs, and requirements for getting medical device products to market in major jurisdictions is preferred.

 

The Culture

At IDE, we work hard for our clients, but we work hard together to ensure the team’s success and the organisations success. In a team of 50, we become good friends quickly solving problems creatively together.  We are driven by our purpose to build better futures and impacting the lives of those who benefit from our innovation.

 

The Benefits

  • Career progression and strong mentoring program

  • Flexible working options available

  • Employee benefits including employee assistance program, fitness classes and social activities

  • Exposure to and working with teams developing the latest medical device innovations

  • Working with diverse group of people

If you are ready to be challenged but fulfilled, have the right skills, experience but most importantly the right attitude, then a truly unique role in a life changing product Development Company awaits. Please email the following at hr@idegroup.com.au

  • CV

  • A short introduction telling us about your educational background, relevant experience and what interests you about the role