Quality Assurance Specialist (Healthcare Logistics, fulltime)

For one of the world's leading companies in medical devices, we are looking for an experienced

Quality Assurance Specialist (Healthcare Logistics, Venlo, fulltime)

The Quality Assurance Specialist will play an important role to ensure that the Quality Management System meets all legal, corporate, and regulatory standards (ISO 13485, EU MDR, FDA, etc.) for all the medical devices products.
You will own and continuously improve QMS processes, act as a liaison for the EDC in Venlo, during change and improvement initiatives, and drive process excellence across the organization.

TASK & RESPONSIBILITIES

• Supports QMS compliance with the appropriate internal and external regulatory requirements
• Support and lead activities related to non-conformances and Corrective and Preventive Actions within the European Distribution Center (EDC)
• Product complaint handling locally (gathering of required Information, Report to legal manufacturer through the complaint Handling Database).
• Support internal and external quality system audits to ensure compliance with regulatory requirements;
• Assisting in maintaining and development of the applicable ISO quality management systems (ISO 13485) and certifications.
• Drive Continuous Improvement and LEAN initiatives in collaboration with internal and external partners.
• Collaborate with cross-functional teams and act as a quality ambassador, promoting risk management, process discipline, and a culture of excellence.

You will be part of a global team dedicated to improving healthcare through innovation and excellence. This role offers the opportunity to work in a dynamic environment, influence key quality initiatives, and grow within a culture that values collaboration, integrity, and continuous improvement.

You get a direct contract with an international, fast growing company, good salary (+bonus), great careerpossibilities and:

• 40 working hours/week;
• Competitive salary depending on experience with a bonus scheme
• 8,5 % holiday allowance
• 27 holidays per year on full time basis;
• Travel allowance
• Collective Health insurance available
• Meaningful innovation, growth and great career opportunities in a dynamic and fast paced work environment.

• You have an education on a Bachelor-level, preferably in Engineering, Quality or a related technical field;
• A few years of working experience in a similar Quality-position within a regulated industry (medical devices preferred);
• experience with LEAN / Six Sigma or similar continuous improvement methodologies;
• Excellent analytical, problem-solving, and communication skills;
• Knowledge of ISO 13485, EU MDR, and FDA QSR is not required but is an advantage;
• attention to detail, with a structured and proactive approach;
• Microsoft Office (excellent Excel and Word skills) are used for the role;
• Strong communication skills in English (reading, writing and spoken) required;
• Ability to work in an international team and communicate within all areas of the organization and to work under time pressure in specific situations;
• Basic project management understanding.

Want to know more? Then contact René van den Borst on 06 - 1881 7501.

Interested? Then click on the application button or send your resume to r.vdborst@suc6recruitment.nl

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