Senior Quality Assurance Engineer
4 weeks ago
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
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