Senior Quality Assurance Engineer

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 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.

• 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.