Our client a leading Medical Device Manufacturer is looking to appoint an experienced Design Quality Engineering into their business.
The Design Quality Engineer provides quality function support to the development, maintenance, and changes of design projects. The Design Quality Engineer will ensure compliance with and maintenance of the companies QMS and regulatory requirements within design documents, records and processes.
The Design 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 Design 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 the companies QMS from design and development perspective
• Support external audit activities
KNOWLEDGE AND SKILLS TO BE SUCCESSFUL IN THE JOB
Education Required: Bachelor degree in academia e.g. Science, Engineering, Quality or equivalent/ related subject.
Education Preferred: Engineering/Science Degree Years of related experience: 2+ years’ experience in a regulated environment.
Quality systems, auditing and supplier/purchasing controls, engineering or equivalent experience desirable.
(Medical Device, automotive, aerospace. Electronics Med Device preferable)
REQUIREMENTS:
• Knowledge of regulatory requirements including ISO 14971, ISO 13485, and FDA Quality System Regulations
• Electronic technical knowledge and experience
• Experience of creating and executing Design/NPI – New Product Introduction projects, preferably within the quality function
• Experience of drafting and implementing Design/Quality documents and protocols: e.g. Validation, FMEA, test documents, etc.
• Must be able to work within a team in a dynamic environment and interact effectively at all levels and across all functions within the organization
• Flexible mindset to adapt to evolving requirements within a small, dynamic work environment
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages
• Excellent English (both oral and written)
• Experience in interacting with regulatory agencies (FDA, MHRA, TUV, etc.) advantageous
• Ability to be the voice of quality when dealing cross functionally with development & other departments