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