Senior Quality Assurance Engineer

About Your New Employer

Join a global leader in medical technology, services, and solutions, dedicated to improving patient outcomes through innovative solutions. You will work on cutting-edge medical devices that comply with international standards, ensuring global reach and influence.

About Your New Job

As the Senior Quality Assurance Engineer you will:

• Ensure products are maintained throughout their lifecycle and comply with global standards.
• Assess patient risk for design changes and provide QA technical direction for qualification and validation activities.
• Generate protocols and compile data for regulatory submissions to support design change approval.
• Work with Regulatory Affairs to present information clearly and minimize agency questions.
• Establish strong relationships across the organization and with partners in a complex technical environment.
• Maintain up-to-date knowledge of regulatory compliance for product design, development, and commercialization.
• Collaborate with engineering and manufacturing to ensure quality standards, conduct tests, and perform statistical analysis.
• May focus on design, material, production control, product evaluation, reliability, inventory control, or R&D as they apply to quality.
• Understand and apply risk management concepts to meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.

What Skills You Need

• Regulatory Knowledge: Expertise in FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
• Technical Direction: Ability to provide QA technical input for qualification and validation activities.
• Design Verification: Experience in generating protocols and compiling data for regulatory submissions.
• Cross-Functional Collaboration: Strong ability to work across various functions and establish effective relationships.
• Quality Assurance: Proficiency in conducting quality assurance tests and performing statistical analysis.

What’s on Offer

• Attractive compensation package.
• Opportunities for continuous learning and growth.
• Work on products that make a difference worldwide.

What’s Next

Apply now by clicking the “Apply Now" button