LSC have a great contract opportunity for Senior Quality Engineer to join a leading medical device company based in Limerick. The companies FDA regulated Limerick facility has grown consistently over the last 20 years to become one of the most important sites in its global operations. This facility specialises in the production of disposable contact lenses in a state-of-the-art operation which includes injection moulding, robotics, vision systems and sterilisation systems in a Class 100,000 cleanroom environment. The facility has over 50 fully automated manufacturing lines and the product is untouched by a human hand from start to finish of the process.
If you have a minimum of 5 years of experience as a professional in a regulated industry, preferred Medical Device and ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES
- 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.
- 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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 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.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Call Conor Dolan in LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert