Job Description
Our client a leading Medical Device Manufacturer is looking to appoint an experienced New Product Development Quality Engineer into their business.
The Design Quality Engineer provides quality function support to the development, maintenance, and changes of design projects. The New Product Development Quality Engineer will ensure compliance with and maintenance of the companies QMS and regulatory requirements within design documents, records and processes.
The New Product Development Quality Engineer will draft and execute required design project documentation such as FMEAs, Validation Protocols, DMRs, Verification testing and technical report writing, etc. to support the execution of design projects.
The New Product Development Quality Engineer will own and lead the completion of NCs and CAPAs associated with design projects.
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Represent the quality function within the design and development team
• Support the design team by drafting, implementing and executing procedures, records and protocols for design and development projects
• Participate in design team meeting to draft, review and implement design projects
• Ownership of design NCs & CAPAs, lead investigations, root cause analysis and corrective action implementation
• Develop metrics/KPIs within the QARA team to implement, maintain, and improve t...