Osborne Recruitment are seeking a Senior Supplier Quality Engineer to join our client’s team based in Swords, Co. Dublin.
Location: Swords, Dublin
Salary: DOE
Your tasks and responsibilities:
As a key member of the team, you will be part of a highly innovative production and Quality network working to deliver high Quality product to serve the needs of laboratories of any size – today and tomorrow.
Act as a key liaison and knowledge transfer champion among Supplier Quality, Quality Assurance, Manufacturing Engineering, R&D, Production and Documentation Control.
Assess suppliers’ capability to meet quality requirements based on data analysis and supplier audit. As a follow-on activity create concise reports that enable project teams to implement improvements and corrective actions.
Use statistical analysis to support suppliers and drive regulatory standards of excellence. Develop world-class supply chain processes to suit a low volume, high complexity multi-technology environment (diagnostic instrumentation).
Work with suppliers in a wide range of Quality relevant areas such as First Articles, general Quality and Regulatory requirements. Work with suppliers on corrective & Preventative Actions, Root Cause Investigations, conduct Supplier Performance Reviews and reporting of Key Supplier Quality metrics.
Your qualifications and experience:
Proven experience in Medical Devices QMS to develop world-class supply chain processes to suit a low volume, high complexity multi-technology environment (diagnostic instrumentation).
Have lead projects to manage suppliers to deliver quality product to internal customers, through product & process investigations & evaluations. Identified and driven process improvements with suppliers.
You will have focused on and been responsible for Supplier process improvements and updating quality system procedures to achieve both fully compliant and lean processes with suppliers.
Minimum of a Bachelor’s degree in a relevant technical discipline (ideally Quality, Engineering or Science). 8 years’ relevant experience in a regulated environment with a core appreciation of FDA regulations and Risk Management incl. writing and / or reviewing Quality related procedures, plans and reports.
Your attributes and skills:
High paced individual who is eager and passionate in developing and delivering quality solutions in close collaboration with suppliers & key stakeholders.
Strong leadership skills and ability to influence cross-functional teams to drive workscope to completion. Self-starter, bias for action with ability to follow assignment through to completion. Good organization skills.
Cross technology and cross discipline collaboration skills. Aptitude for systems level thinking, including development of standard operating procedures. Ability to write structured, concise, unambiguous technical English with high attention to detail. Core understanding of statistical analysis and design of experiment experience. Familiar with statistical software packages e.g., Minitab.
Computer literacy (including MS Word/ Excel/ PowerPoint/ MS Project) and Interface to Product Lifecycle tools such as SAP, Teamcenter or other. Presentation skills whereby complex messages can be presented to an auditor/ inspector in a succinct manner i.e., ability to present and to sell convincingly. Understanding of Immunology, Biochemistry & Hematology diagnostic technologies would be an advantage.
For more information, please apply through the link provided for the attention of Daniel Kirwan or email daniel.kirwan@osborne.ie If you are interested in finding out more about the above role and would like to be considered other suitable roles that we may have available for your skill set – please attach your CV via the link provided Please submit your updated CV in Word Format If you are living in Ireland and hold a valid work permit, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search. Osborne are proud to be an Equal Opportunity Employer.
