Job Description
We are seeking an accomplished Senior Design Specialist to join our team. As a key member of the device development program, you will be responsible for ensuring compliance with design control requirements and relevant regulations.
The successful candidate will possess expertise in medical device development and manufacturing operations activities within a GMP environment.
Key responsibilities include:
* Providing guidance and support throughout the design and development lifecycle.
* Maintaining and providing guidance on Design History Files for development programs.
* Collaborating with stakeholders to ensure appropriate objective evidence and controls are established and maintained.
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Required Skills and Qualifications
To be considered for this role, applicants must possess:
* A degree or masters in engineering or science/life science.
* Industry experience in medical device or pharmaceutical with devices.
* Minimum 5-7 years at similar level or 5-10 years general experience in industry.
* Demonstrated understanding of GMP, Quality Management System, and relevant Regulations.
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Benefits
This role offers a unique opportunity for professional growth and development in a dynamic environment.
The ideal candidate will have:
* Experience in implementing device design controls and ISO/FDA requirements.
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About the Role
This position is an excellent opportunity for a skilled professional to contribute to the success of our organization.
We look forward to hearing from talented individuals who share our passion for excellence.