This role is critical to ensuring medical device products meet the highest quality and regulatory standards throughout their lifecycle.
Key Responsibilities:
* Provide design assurance expertise to support sustaining engineering projects.
* Evaluate and implement product, process, and material changes within manufacturing operations.
* Develop and manage design verification protocols.
* Collaborate with regulatory affairs to ensure accurate information is presented in submissions.
Requirements:
* Bachelor's degree in Engineering, Science, or a related technical field.
* Minimum of 5 years' experience in a quality assurance or design assurance role.
* In-depth knowledge of ISO 13485 and other applicable regulations and standards.
A strong understanding of design control, risk management, and root cause analysis is essential for success in this position.