Senior Quality Engineer
Responsibilities:
- 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.
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