Social network you want to login/join with:
* Provide Design Assurance support for sustaining commercial projects, ensuring continued compliance with global standards throughout the full product lifecycle.
* Support the implementation of changes to products, processes, or materials within manufacturing by assessing patient risk and maintaining quality standards.
* Provide technical QA input for qualification and validation activities in collaboration with R&D and Manufacturing Engineering.
* Develop and execute Design Verification protocols and compile data for shelf life and regulatory submissions related to design changes.
* Work closely with Regulatory Affairs to ensure clear, accurate, and complete submission materials, minimizing follow-up questions from regulatory agencies.
* Foster strong cross-functional relationships across the organization and external partners in a complex technical environment.
* Lead investigations into quality issues and ensure timely, thorough completion.
* Support continuous improvement by generating and approving change requests and corrective actions.
* Collaborate with engineering and manufacturing to uphold quality standards and drive compliance throughout operations.
* Contribute to the design and specification of inspection and testing equipment; perform quality assurance tests and statistical analysis.
* Ensure that all corrective actions meet required reliability standards and that documentation meets internal and regulatory compliance requirements.
Requirements:
* Expertise in design assurance and quality engineering principles within a regulated industry.
* Experience with qualification and validation processes and risk assessment in support of product and process changes.
* Proficiency in creating and executing Design Verification protocols and preparing regulatory submission documentation.
* Strong knowledge of global regulatory standards related to product design, development, and commercialization.
* Demonstrated ability to work cross-functionally in a technical environment and build collaborative relationships.
* Excellent analytical, problem-solving, and investigation skills.
* Familiarity with statistical analysis, inspection and testing techniques, and quality assurance methods.
* Ability to lead or contribute in specialized areas such as design quality, incoming material inspection, production control, or R&D quality support.
#J-18808-Ljbffr