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Regional Quality Specialist

Apply now Job no: 615519
Work type: Permanent
Location: Addlestone
Categories: Quality & Regulatory, Western Europe, Individual Contributor

About Us

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. Our mission is to help more people to hear.

The Opportunity

Cochlear is now offering a permanent position for a Regional Quality Specialist to provide support to the EMEA region and their quality activities. This fantastic role provides support to the Quality Management System and ensures compliance with the company, customer and regulatory quality standards. 

Your responsibilities will include…

  • Support and maintain QMS processes to help ensure a state of audit readiness and compliance
  • Act as a Process Editor for the QMS documentation and support stakeholders to publish
  • Routine management of the issue management process, including quarantine, monitoring actions, and escalation to manufacturers
  • Maintain and support a state of “audit readiness” within the supply chain network
  • Facilitate and support Declarations of Conformity, Protocols of Analysis and Certificates of Sterility as required by regional regulations and business requirements
  • Support product life cycle processes within the region including product launch, change and retirement
  • Role model risk-based decision making and global quality team behaviours
  • Provide one to one support on request for regional use and interaction with the QMS
  • Develop e-learning modules / training materials on topics of subject matter expertise
  • Support generation and maintenance of QMS training matrices 

About You:
Minimum:

  • Good attention to detail, analytical and logical
  • Strong planning and organisational skills
  • Good written and verbal communication skills
  • Good PC skills including using MS Word, Excel and PowerPoint

Ideal:

  • Experience working in a medical device or life sciences technology driven company
  • Experience working with problem solving methodologies and process development tools
  • Understanding of ISO 9001 / 13485, and EU Regulations

Developmental Value of the role:

Cochlear is a global organisation spanning sales in over 100 countries, with operations teams based in the United States, throughout Europe, Middle East, Africa, and the Asia Pacific region. This role offers you an opportunity to work across organizational boundaries. You will be able to demonstrate and further develop your teamworking skills through collaboration and coaching others in quality related areas. This is a chance for you to really test your problem-solving skills by tackling challenging technical problems whilst working effectively in a team environment. The role will provide you a unique opportunity to further build on our current success and help shape us for future exponential growth.

Cochlear Summary

Cochlear’s mission is to help more people to hear. 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.

#CochlearCareers

At Cochlear we value and welcome the unique contributions, perspectives, experiences and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. We offer flexible working arrangements, and we understand flexibility is not the same for everyone. We're open to a conversation about what flexibility means for you.

 

Advertised: GMT Standard Time
Anticipated Application Closing:

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