Senior quality assurance engineer (fulltime)

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

SENIOR QUALITY ASSURANCE ENGINEER (fulltime)

This company is known for its innovative products and solutions in the healthcare industry. As a SENIOR QUALITY ASSURANCE ENGINEER, you will play a key role within the Global QA Team, ensuring that the QMS (Quality Management System) meets all legal, corporate, and regulatory standards ( ISO 13485, EU MDR, FDA, etc) for all medical devices products. You will own and continuously improve QMS processes, act as a liaison for the CDC in Venlo,during change and improvement initiatives, and drive process excellence across the organization.

The 'SENIOR QUALITY ASSURANCE ENGINEER' is responsible for:

• Own and maintain QMS processes, including Training, Document and Record Control.
• Support and lead activities related to non-conformances and Corrective and Preventive Actions.
• Develop, implement, and monitor QA processes, providing regular updates to stakeholders.
• Drive Continuous Improvement and LEAN initiatives in collaboration with internal and external partners.
• Support internal and external audits and ensure compliance with regulatory requirements.
• Lead QA efforts related to Value Added Services such as labeling, kitting, and other CDC operations.
• Collaborate with cross-functional teams and design divisions on new process setups, M&A integrations, and organizational change.
• 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 at least a Bachelor’s degree (or equivalent) in Engineering, Quality or a related technical field.
• Minimum 3 years of experience in Quality Assurance within a regulated industry (medical devices preferred).
• Strong understanding of ISO 13485, EU MDR, and FDA QSR requirements.
• Proven experience applying LEAN / Six Sigma or similar continuous improvement methodologies (Green Belt or higher).
• Excellent analytical, problem-solving, and communication skills.
• Strong attention to detail, with a structured and proactive approach.
• Excellent communication and interpersonal skills, fluent in English (written and spoken)
• Structured, tidy and precise
• Experience working in a medical device (distribution or manufacturing) environment (pré)
• Familiarity with process automation tools or digital QMS platforms.
• Advanced knowledge of MS Office, especially Excel.
• Team player, quick learner, able to work in a dynamic organization, and be able to work from home.

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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