Regional Senior Quality Specialist - EU

C68 Cochlear Deutschland GmbH and Co. KG – Dutch branch; Venlo; On-site; EUR 65,000 - 90,000; Full time

Job summary

Cochlear is seeking a Regional Senior Quality Specialist to establish and maintain the EMEA Quality Management System within the EU Distribution Center. You will provide hands-on quality support, drive core processes, and lead improvements across the region.

This 12-month contract offers a path to permanent status within a collaborative Quality team. Ideal candidates have 3+ years in medical device quality, strong knowledge of ISO 13485 and EU MDR, and experience with audits, CAPA, and

Qualifications

• 3+ years of medical device quality experience at specialist level.
• Experience implementing or enacting quality processes and reporting tools.
• Knowledge of ISO 13485 and EU MDR quality system requirements.
• Experience with non-conformance management, audits, investigations, root‑cause analysis and corrective actions.

Responsibilities

• Manage key operational quality processes (NCRs, quarantine, quality holds, field actions, line clearance).
• Provide onsite quality support to the EU Distribution Center, including goods‑in inspection oversight and stock controls.
• Conduct internal audits and support regulatory audits and regional manufacturing activities.
• Support investigations of customer complaints and lead root‑cause analysis and CAPA communications.
• Enact QMS processes including document control, training and management review.

Skills

Quality management

Regulatory compliance

Risk-based decision making

Project management

Audits & CAPA

Tools

ISO 13485

EU MDR

Job description

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.

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 walk‑arounds 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.

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

Our growth is creating great opportunities! Our team is expanding and we want to hire the most talented people we can. Continued success depends on it. So once you've had a chance to explore our current open positions, apply to the ones you feel suit you best and keep track of both your progress in the selection process, and new postings that might interest you! We're the global leader in implantable hearing solutions. We have provided more than 600,000 implantable devices, helping people of all ages to lead full and active lives. We help people hear and be heard. We empower people to connect with others and live a full life. We help transform the way people understand and treat hearing loss. We innovate and bring to market a range of implantable hearing solutions that deliver a lifetime of hearing outcomes.