Based upon his own domain of technical experience, the R&D Quality Assurance specialist is responsible to develop and maintain practical and innovative ways for assuring that the design of the product meets business needs in compliance with applicable Design Controls as well as any other internal or external standards that may apply.
The incumbent will provide direction and assistance to other QA, R&D, Project Leaders, and Project Teams for design controls, safety risk management, and lead continuous improvement of the company product lifecycle management processes.
MAIN ACCOUNTABILITIES Serve as Quality referent for R&D projects (instruments) in regard to the Product Development and Life Cycle Management Processes, Design Control for instrument or system.
Provide Quality Engineering tools and methods.
Guarantee the compliance of the product Risk Management process (safety, dFMEA) in EME or North America sites for instrument/system development.
Support the instrument/system project leaders to design planning and deliverables (internal or from subcontractors) to ensure compliance.
Review the auditability of DHF.
Lead for QA Product Life Cycle and R&D improvement initiatives while balancing Time To Market, cost, and quality objectives.
This can be done by supporting the development of Quality Plan(s), guides, or procedures and the establishment of indicators to measure effectiveness.
Serve as chairperson (or committee member) for design reviews, as appropriate.
Perform and conduct audits (internal and external audits).
Provide input into training modules, procedures, guidelines, and perform training for Design Control elements.
Interface with the team responsible for the delivery of the documentation required by the CE marking in relation to Regulatory Affairs.
Contribute to CAPA and complaint handling managed in R&D (through the follow-up of investigation and root cause analysis) when linked to design.
Contribute to the Change Review Boards during the Development Process or for design changes occurring after the launch of the instrument/system.
Guide the R&D Engineering department for the implementation of relevant QA procedures; training of personnel on those procedures.
Be the R&D interface with internal and external auditors.
SKILLS AND COMPETENCES An engineering degree and at least 5 years of work experience in a relevant industry in R&D, including at least 3 years in quality assurance.
Knowledge of quality standards such as ISO 9001, ISO 13485, ISO 14971, and other safety standards (electrical and mechanical).
Knowledge of US 21 CFR Part 820 and related CFR, 2017/746/EU IVD Regulation, and main other product connected directives/regulations.
Skilled in R&D development processes and technical aspects.
Ability to work in an international context, independently or in a team environment.
Strong communication skills and leadership.
Advanced competence in the selection and use of Quality Engineering tools and techniques.
Location: Florence site #J-18808-Ljbffr