Senior Supplier Quality Engineer
The team:
My client is a global medical device organization of more than 70,000 highly dedicated employees across more than 70 countries. Their portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Your tasks and responsibilities:
* 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. 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 led 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 work scope to completion. Self-starter, bias for action with ability to follow assignments 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 contact Alan on alan@accpro.ie
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Manufacturing, Quality Assurance, and Production
Industries
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Manufacturing
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