EMEA Staff Quality Specialist Service&Repair, Orthopedics, Amsterdam

Job location: Amersfoort, Utrecht, Netherlands Key Responsibilities

Be the main point of contact for quality and compliance aspects for EMEA Service Centers Ensure general compliance support for consistent and correct execution of QS procedures at all Service Centers e.g. change management strategies Be the subject matter expert for the validation of equipment and computer system validation of equipmentEnsure qualification and management of suppliers related to Installation&Servicing Collaborate with Service Operations to ensure global harmonization of service processes. Collaborate with Customer Quality representatives to ensure compliance with reporting requirements of all Service centers and accuracy of service evaluations linked to customer complaints Support tracking of monthly performance and quality metrics for each Service Center and attend the monthly/annual review meetingsCoordinate and support resolution for all nonconformances, CAPAs and audit observations related to Installation and Servicing for the Netherlands Service Center and regional QMS Collaborate on shared/global procedures update and harmonization Support Service Sites internal and external audits based on sites requirementsConduct training related to procedural changes and coordinate with relevant stakeholders to investigate and document deviations identified at the sites. Manage the initiation and review of Service Level Agreements Responsible for communicating business related issues or opportunities to the next management levelConduct data driven analysis based on requirements Lead continuous improvement initiatives to ensure efficiency, effectiveness, and complianceMaintain awareness of ISO standards while developing solutions to satisfy business needs Required Qualification and Core Competencies for the role

Bachelor degree in engineering, scientific or quality and compliance disciplines. Will accept the equivalent relevant industry experience in the absence of a degree At least 5 years experience in Quality (medical devices and validation of equipment preferred) Recommended Lean six sigma Green/Black belt, Project Management Certification will be an asset for this positionExperience in regulated ISO 13485 industries Excellent communications skills Organizational skills, ability to resolve conflicts Strong analytical thinking skills and the ability to work in a flexible way under time pressure in local and global teams Ability to make risk based decisions under time pressureUnderstands the business implications regarding quality positions and decisions High sense of responsibility and reliability Work independently within established timelines Experience with ETQ, Windchill and MD S&R will be beneficial Fluent in English Ability to travel if and when required Required Skills

Corrective and Preventive Action (CAPA) Quality Control (QC) Quality Validation Preferred Skills

Audit Management Business Savvy Coaching Communication Compliance Management Continuous Improvement Fact-Based Decision Making ISO 9001 Issue Escalation Problem Solving Quality Management Systems (QMS) Quality Standards Regulatory Environment Standard Operating Procedure (SOP)

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