Role OverviewThe Design Quality Engineer position is responsible to implement and lead Design Quality Engineering activities at the DJO design and production location(s) as assigned. The Design Quality Engineer will support priority Product Development and Sustaining Design Engineering projects as the lead Quality Engineering technical representative.
What You Will Do
Assists process owners to write and issue procedures to assure compliance with the current FDA QSR regulations, ISO 13485, CMDR and Medical Device Directive requirements; and to provide training to process owners related to Quality Management System requirements, as necessary. Supports Design Quality Engineering Assignments, including New Product Introduction (NPI) projects, Corporate priority projects and sustaining support.
Why It Might Be a Fit
Requires certification to perform audits. Certification may be obtained through successful completion of an RAB auditor course, successful completion of CQA (Certified Quality Auditor) or on-the-job training by another qualified internal auditor. Requires experience in biomedical engineering standards and concepts. Required knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.
Requirements
- Bachelor's degree in Science or Engineering
- 3 plus years of experience
- CQA or RABQSA, CQE or CMfgE certification
- Certification to perform audits
- Experience in biomedical engineering standards and concepts
- Knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards
Benefits
- Equal employment opportunities
- Reasonable accommodation to employees' beliefs and practices
]]>