Senior Quality Expert

2 weeks ago

Sydney, New South Wales, Australia beBeeQuality Full time $70,000 - $100,000

At our organization, we are dedicated to creating meaningful outcomes by living our values: be resourceful, be curious, think positive, put others first, embrace complexity and take ownership.

Our purpose is to build better futures every day. We collaborate together in smart ways to bring products to life.

We are a team of intelligent people who love working with us for the variety of projects and intellectual challenges.

Our engagement surveys over the last 3 years have revealed that our people love working with us because:

  • The people - collaborating together in smart ways
  • Our purpose - building better futures every day
  • The variety of projects and intellectual challenges
Job Description

We are seeking a Senior Quality Associate who is a proactive, passionate team player, driven by solving complex challenges. You'll be comfortable in making decisions in an environment of uncertainty, be able to apply critical thinking skills and be willing to challenge the status quo.

This role involves providing guidance/direction on product development activities, ensuring adherence to guidelines and the requirements of our QMS and best practice design controls.

You will review product development and manufacturing documentation to provide input on compliance and the quality of project deliverables being created.

Advise on suitable approaches and required documentation as part of regulatory submissions for medical devices.

Use your product development, commercialisation and quality assurance experience to support strategy development, budgeting and planning engineering activities for product development, commercialisation and manufacturing projects.

Identify areas where process scaling can be applied to ensure a safe and effective device is developed while optimising the use of engineering resources within the projects.

Actively collect, analyse data and information within product development projects and our QMS.

Support management of key QMS processes including equipment calibration, supplier qualification, and Corrective and Preventive Actions.

  • A degree in Mechanical, Mechatronics or Biomedical Engineering, Industrial Design or similar applicable technical discipline.
  • Minimum 5 years of experience working in product development projects either in product development or quality assurance role.
  • Experience working in an ISO 13485-compliant QMS.
  • Understanding of key Medical Device standards including ISO 14971 and IEC 62366.
Required Skills and Qualifications

Key qualifications include:

  • Experience in undertaking product realisation and manufacturing planning, quality control and process validation in medical device manufacturing environments.
  • Strong Microsoft Office skills, particularly Word and Excel.
Benefits
  • Career progression and a strong mentoring program
  • Employee benefits including an employee assistance program
Others

As a Senior Quality Associate, you will report directly to the Business Unit senior manager and work closely with cross-functional teams to drive quality initiatives forward.

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