Senior Design Quality Specialist
The primary objective of this role is to develop design requirements and manufacturing processes that support the successful launch of new products. Key responsibilities include creating quality documentation, collaborating with cross-functional teams to lead product transfer and development activities, and identifying risks associated with product development.
Key Requirements:
* Extensive experience in medical device product development lifecycle, including risk management, usability, and design/process verification and validation.
* Strong knowledge of Packaging Development/Manufacturing process and related standards.
* Demonstrated expertise in Advanced Quality tools such as Failure Modes and Effects Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
* Ability to interpret CAD drawings and collaborate with regulatory agencies.
* Bachelor's Degree in a science, engineering or related discipline with MS, CQE, or CRE preferred.
Benefits
This role offers opportunities for professional growth and development in a dynamic environment. The ideal candidate will have a passion for delivering high-quality results and making significant contributions to product development projects.