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Contact Info
Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Senior Supplier Quality Engineer


Reference:SMC5769 Location: Limerick
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Quality Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties

• Performs quality processes including; change control, supplier non-conformance, quality agreements. Participate in local site supplier/EM quality meetings to ensure communication and alignment of quality initiatives. Lead supplier/EM quality evaluations. Provide third party inspection support.
• Lead defect resolution, root cause investigation, and continuous improvement activities. Collaborate across functions to confirm if non-conformances are supplier/EM related as applicable.
• Support internal and/or external cross-functional and cross sector project teams driving supplier/EM improvement and general initiatives through reducing variations in supply chain, institute control plans, and improving process capability. Provide Quality Engineering support to suppliers/EMs including verification/validation activities. Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Fault Three Analysis (FTA), Root Cause Analysis, Design of Experiment (DOE) etc., to the development of new products or processes related to raw materials, services, and finished products.
• Maintain, support compliance of, and improve supplier/EM quality processes, including procedural and electronic systems. Support alignment with enterprise standards and executing gap assessments. Provide regulatory guidance and interpretation to internal and external partners with regards to the following areas: EM and Supplier Quality procedures, medical devices, and combination products.
• Accountable, as applicable for compliance in accordance with regulations such as and from, but not limited to, FDA Quality System Regulation, ISO 13485, EU MD Directive/Regulations, FDA, 21 CFR 820; FDA Combo Product Regulation 21 CFR Parts 4 with 21 CFR 210/211, Japanese MHLW, Health Canada, Brazilian ANVISA, Australian TGA for the company's products including medical devices and combination products.


Education & Experience

• Experience as a professional in a regulated industry, preferred Medical Device
• Demonstrates a basic understanding of the Medical Device Quality Systems, emphases on purchasing controls.
• Require working knowledge of Word, Power Point and Excel with competency in moderately complex functions for data analysis and trending.
• Experience in the Medical Device industry is preferred. Experience in the Pharmaceutical industry or Chemical, Packaging, or Plastics industry is an asset.

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.