Regional Quality Specialist
Cochlear
Addlestone
5d ago

Overview

This is a great opportunity to support the growing Cochlear EMEA business. If you want to work across a region and you possess excellent communication and collaboration skills with the ability to influence and drive a change management process, then this is the role for you!

Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions.

This is a great opportunity to support the growing Cochlear EMEA business. If you want to work across a region and you possess excellent communication and collaboration skills with the ability to influence and drive a change management process, then this is the role for you!

Working as part of a forward-thinking quality team, you will work with stakeholders across the world to develop and improve the systems needed to meet the significant changes in regulatory requirements for medical devices in Europe.

Broad Content of Role :

The Regional Quality Specialist is responsible for providing support and consultation to the regional business unit in quality system and quality operations activities.

This includes Cochlear owned entities within the region as well as third parties involved in the distribution of Cochlear products.

Duties and Responsibilities :

The Regional Quality Specialist manages the control of the downstream supply chain to ensure that safe, working product gets from Cochlear to our customers.

It works with the internal stakeholders and third-party distributors to educate, engage and enable them to implement appropriate and effective quality process controls.

You will be involved with :

  • Establishing, implementing and maintaining quality management system processes
  • Supporting quality processes to achieve an appropriate level of risk-based assurance
  • Project planning and delivery of process change
  • Collaborating, coaching and educating stakeholders (internal and external)
  • Conducting risk-based reviews of compliance
  • Internal and 2nd Party auditing
  • Continual improvement and alignment / harmonisation of processes
  • Key Requirements :

    3+ year’s quality experience in a regulated industry

    Experienced at effective communication and collaboration, with the ability to influence and drive a change management process

    Experience with implementation of processes, systems and reporting tools

    Highly organized and experienced in project management and deliverables

    Experience with continuous improvement methodology and process control techniques

    Experience working in a medical device or life sciences technology driven company would be a benefit

    Experience in ISO 13485, and EU Regulations

    General :

    Cochlear’s mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other.

    Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.

    Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always. Cochlear is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).

    Equal opportunities

    Cochlear is committed to providing equal opportunities to avoid unlawful discrimination on the grounds of race, sex, disability, sexual orientation, religion / belief or age.

    In line with our corporate ethics and statutory obligations we strive to ensure that the work environment is free of harassment and bullying and that everyone is treated with dignity and respect -

    this is an important aspect of ensuring equal opportunities in employment.

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