EMEA Staff Quality Specialist Service & Repair, Orthopedics

360Pharma; Netherlands; On-site; EUR 75,000 - 110,000; Full time

Job summary

360Pharma in Amersfoort, Netherlands seeks a Quality & Compliance expert to lead quality programs for EMEA service centers and ensure ISO 13485 compliance across equipment validation and supplier management.

You will drive CAPA, change control, audits, and continuous improvement in a regulated medical devices environment, collaborating with global teams and travel as required. Fluent English is essential.

Qualifications

• Bachelor degree or equivalent in engineering, science or quality/compliance disciplines.
• At least 5 years of Quality experience in medical devices and validation of equipment preferred.
• Lean Six Sigma Green/Black Belt recommended; PM certification an asset.
• Experience in regulated ISO 13485 industries.
• Excellent communication and organizational skills.
• Ability to work under time pressure in global teams.
• Fluent in English and travel-ready if required.

Responsibilities

• Be the main contact for quality and compliance for EMEA Service Centers.
• Ensure general compliance support for QS procedures at all Service Centers.
• Lead validation of equipment and computer systems.
• Manage qualification and supplier oversight for Installation & Servicing.
• Collaborate with Service Operations to harmonize service processes.
• Support reporting, CAPAs, audits, and deviation investigations.
• Track monthly quality metrics and participate in reviews.
• Coordinate audits and internal/external requirements for the Netherlands Service Center.
• Contribute to updating global procedures and harmonization.
• Provide training on procedural changes and document deviations.
• Manage initiation and review of Service Level Agreements.
• Communicate business issues or opportunities to management.
• Conduct data-driven analysis and lead continuous improvement.
• Maintain awareness of ISO standards while solving business needs.

Skills

CAPA

QC

Quality Validation

English Fluent

Risk Based Decisions

Education

Bachelor degree in engineering/science/quality disciplines

Tools

ETQ

Windchill

MD S&R

Job description

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 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 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 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)