Chief product compliance officer

Design Assurance Specialist

As a key member of the product development team, you will play a critical role in ensuring the ongoing maintenance of commercial products throughout their full lifecycle. This involves supporting compliance with global quality and regulatory standards.

* Ensure sustained compliance of commercial products through all phases of the product lifecycle.
* Evaluate and manage design changes in alignment with regulatory and quality requirements.
* Provide QA technical direction for product qualification and validation in collaboration with R&D and Manufacturing Engineering.
* Generate design verification protocols and participate in compiling verification and shelf-life data for regulatory submissions.
* Interface with Regulatory Affairs to present data clearly and minimize questions from regulatory agencies.
* Build strong working relationships across R&D, Regulatory Affairs, Quality, and Manufacturing teams.
* Support implementation of design, process, and material changes within manufacturing operations.
* Maintain current knowledge of global regulatory and compliance requirements (e.g., FDA, ISO).
* Generate and approve change requests and ensure documentation meets regulatory standards.
* Lead or support timely investigations and root cause analysis for quality issues.
* Apply risk management principles throughout product development and post-market activities.
* Ensure risks are properly assessed, documented, and mitigated per industry standards.
* Collaborate with engineering and manufacturing to ensure quality standards are met.
* Design or specify inspection/test mechanisms and conduct quality assurance testing.
* Perform statistical analysis on nonconforming materials to determine root cause and assign responsibility.
* Ensure corrective actions meet reliability and documentation standards.
* Provide support in design, incoming material quality, production control, product evaluation, inventory control, and/or R&D quality as applicable.
* Partner with the complaints team for complex product investigations and resolution.
* Strong knowledge of FDA regulations and ISO standards.
* Experience in sustaining engineering, design assurance, or medical device quality systems.
* Demonstrated ability to manage risk, drive quality improvements, and support regulatory submissions.