Regional Senior Quality Specialist - EU

Cochlear Limited; Venlo; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cochlear Limited in Venlo, NL, is seeking a Regional Senior Quality Specialist to help establish and maintain the EU/EMEA QMS for the EU Distribution Center. You will provide hands-on support to site operations, drive audits, CAPA, change controls and supplier quality, and partner with Quality, Supply Chain and Operations to ensure regulatory compliance.

The role is initially for 12 months with potential to become permanent, requiring strong experience in medical device quality, ISO 13485 and EU

Qualifications

• At least 3 years of medical device quality experience.
• Experience implementing quality processes, systems and reporting tools.
• Knowledge of ISO 13485 and EU MDR requirements.
• Experience with audits, non-conformance, investigations and CAPA.
• Strong project management and stakeholder management.
• Excellent communication across all levels of the organization.
• English fluency required; Dutch and/or German desirable.

Responsibilities

• Manage key operational quality processes including NCRs, quarantine, holds, field actions, line clearance and escalation to manufacturers.
• Provide onsite quality support to the EU Distribution Center, including goods-in inspection oversight and stock controls.
• Conduct routine internal audits and support regulatory audits and regional manufacturing activities.
• Support regional investigations of customer complaints and facilitate root cause analysis, CAPA communications.
• Enact and support QMS processes covering document/control, change control, training, internal audit, and management review.
• Support product introduction, change and retirement activities for EU importer/distributor compliance.
• Partner with Supply Chain and operations through regular meetings to progress quality actions.
• Review new and changed QMS documents and guide partners through process changes.
• Design and deliver quality training and promote quality awareness across the site.
• Lead continuous improvement projects across the region to streamline processes and strengthen controls.

Skills

Quality management

Regulatory compliance

Project management

Communication skills

Stakeholder management

Job description

## Regional Senior Quality Specialist - EUApply: NL Venlo: Full time: Posted Today: R-624257## **Please submit your application as soon as possible, as we reserve the right to close this advertisement at any time.**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 projectsIf 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.