EMEA Staff Quality Specialist Service & Repair, Orthopedics

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 equipment
• Ensure 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 meetings
• Coordinate 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 requirements
• Conduct 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 level
• Conduct data driven analysis based on requirements
• Lead continuous improvement initiatives to ensure efficiency, effectiveness, and compliance
• Maintain 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 position
• Experience 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 pressure
• Understands 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)

Location: Amersfoort, NL