Senior Quality Assurance Engineer
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Job Location:
Venlo - Netherlands
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
As a Senior Quality Assurance Engineer you will play a key role within the Global QA Team ensuring that our Quality Management System meets all legal corporate and regulatory standards (ISO 13485 EU MDR FDA etc.) for all the Stryker products.
You will own and continuously improve QMS processes act as a liaison for the CDC during change and improvement initiatives and drive process excellence across the organization.
Key Responsibilities
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.
Requirements
Required:
You have at least a Bachelors 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.
Fluent in English (written and spoken). Any other language is a plus.
Preferred:
Experience working in a medical device distribution or manufacturing environment.
Prior involvement in M&A integrations or multi-division quality initiatives.
Familiarity with process automation tools or digital QMS platforms.
Advanced knowledge of MS Office especially Excel.
Why Join Us
At Stryker 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.
Required Experience:
Senior IC
Key Skills
- Continuous Integration
- APIs
- Jenkins
- Test Cases
- Performance Testing
- Quality Assurance
- Agile
- Jira
- Software Testing
- Java
- Test Automation
- Selenium
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
