Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a world full of sound. We aim to transform the way people understand and treat hearing loss and innovate to connect people with future technologies. 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 more people to experience a lifetime of hearing.
The Opportunity
As a Regional Senior Quality Specialist, you will help establish, implement and maintain the EMEA Quality Management System within the EU Distribution Center, ensuring products, facilities and operational processes meet applicable quality, regulatory and business requirements.
You will provide hands-on quality support to site operations, manage core quality processes and use data, audits and risk-based decision-making to monitor effectiveness and maintain audit readiness.
Working closely with Quality, Supply Chain, Operations, manufacturers and regional stakeholders, you will also support product lifecycle activities, strengthen quality awareness and lead improvements across the distribution center and region.
This role is offered on an initial 12-month contract and provides the opportunity to become a permanent member of a growing and highly collaborative Quality team.
What you will do:
- Manage key operational quality processes, including non-conformance reports (NCRs), quarantine, quality holds, field actions, line clearance and escalation to manufacturers.
- ·Provide onsite quality support to the EU Distribution Center, including goods-in inspection oversight, facility walkarounds and monitoring of facility and stock controls.
- Conduct routine internal audits and help maintain continuous audit readiness, including support for external regulatory audits and regional manufacturing activities.
- Support regional investigations of customer complaints and facilitate root cause analysis, corrective actions and CAPA communications.
- Enact and support QMS processes covering document and records management, change control, training, internal audit, management review and quality objectives.
- Support product introduction, change and retirement activities, including EU importer and distributor compliance for third-party products.
- Partner with Supply Chain and operational teams through daily, weekly and monthly meetings, representing Quality and progressing actions that support compliant supply.
- Review new and changed QMS documents and guide business partners through process development, procedural change and implementation.
- Design and deliver quality training and help build a strong culture of quality awareness across the site.
- Lead continuous improvement projects across the region, identifying practical ways to streamline processes and strengthen operational controls.
About You:
- You combine strong quality expertise with a practical, solutions-focused approach to supporting operations in a regulated environment.
- You are comfortable handling complex problems, using evidence and risk-based thinking to reach sound decisions.
- You are highly organised and able to manage projects, actions and deliverables across multiple stakeholders and priorities.
- You communicate clearly at all levels and can influence colleagues across Quality, Supply Chain, Operations and other functions.
- You enjoy improving processes, sharing knowledge and helping others understand how quality requirements apply in day-to-day operations.
Required Skills & Experience:
- At least 3 years of proven medical device quality experience at specialist level within a medical device or life sciences technology company.
- Experience implementing or enacting quality processes, systems and reporting tools.
- Knowledge and practical experience of ISO 13485 and applicable European requirements, including EU MDR quality system requirements.
- Experience with operational quality in a sales and distribution environment.
- Experience with continuous improvement methodologies and process control techniques.
- Experience supporting non-conformance management, audits, investigations, root cause analysis and corrective actions.
- Strong project management, organisational and delivery skills.
- Ability to quickly develop detailed knowledge of a broad product portfolio.
- Excellent communication and stakeholder management skills across all levels of an organisation
Languages:
- Fluent in English – Dutch and German are desirable but not mandatory
Desired Skills:
- Experience within a medical device company that designs, manufactures and distributes active implantable medical devices.
- Experience developing and delivering presentations or quality training.
- Experience supporting product lifecycle activities, third-party distributors or regional quality agreements.
- Experience leading cross-functional process improvement projects
If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.
#CochlearCareers
How we recognise your contribution
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. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.
For more information about Life at Cochlear, visit www.cochlearcareers.com
Skills Required
- At least 3 years of medical device quality experience at specialist level within a medical device or life sciences technology company
- Experience implementing or enacting quality processes, systems, and reporting tools
- Practical knowledge of ISO 13485 and applicable European requirements, including EU MDR quality system requirements
- Experience with operational quality in a sales and distribution environment
- Experience with continuous improvement methodologies and process control techniques
- Experience supporting non-conformance management, audits, investigations, root cause analysis, and corrective actions
- Strong project management, organizational, and delivery skills
- Ability to develop detailed knowledge of a broad product portfolio
- Excellent communication and stakeholder management skills
- Fluent English
- Dutch language skills
- German language skills
- Experience at a medical device company designing, manufacturing, and distributing active implantable medical devices
- Experience developing and delivering presentations or quality training
- Experience supporting product lifecycle activities, third-party distributors, or regional quality agreements
- Experience leading cross-functional process improvement projects
What We Do
Hear now. And always As the global leader in implantable hearing solutions, at Cochlear (ASX: COH) we are committed to our mission to help people hear and be heard. Our story started more than four decades ago when Professor Graeme Clark pioneered the world's first multi-channel cochlear implant and created an entirely new treatment for hearing loss. Since our formation in 1981, we continue Professor Clark’s work to help people with moderate to profound hearing loss experience a life full of hearing. We have provided more than 650,000 implantable devices. Each recipient helps form a global community of millions, through families, friends, colleagues, teachers and more. And they’re not just connected to their own community — each shares a link with each other and to Professor Clark’s childhood desire to help people hear. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We understand the privilege of connecting people to a life lived with hearing. And we listen, respond and move with the times – to continue to bring hearing within reach of all those who need it. That's how we live our mission every day. Our global workforce of more than 4,000 people shares a collective determination to give more people the opportunity to enjoy a life of hearing. Cochlear’s global headquarters are on the campus of Macquarie University in Sydney, Australia with regional headquarters in Asia Pacific, Europe and the Americas. Through our offices in over 180 countries we help people of all ages to hear. Social Media Terms of Use http://bit.ly/2qRMEvY
