Senior Quality Manufacturing Engineer
Our client, a medical device company in Westmeath are currently looking to recruit a Senior Quality Manufacturing Engineer for their site.
The Senior Design Quality Engineer position is one of development, improvement and innovation, if you pride yourself on your problem solving skills, meticulous attention to detail and passion for quality this may be the role for you. You will be tasked to provide quality engineering support in design and development of medical device products, Airways, Breathing Circuits and Inhalation. Facilitate the application of design controls in product development and sustaining changes. Provide support in the rapid resolution of product complaints and / or safety issues.
As a Senior Design Quality engineer, your key responsibilities will involve, reviewing new and modified product designs for quality characteristics - including manufacturability, serviceability, testability, reliability, and product requirements. You will ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations. You will participate on cross-functional teams to develop product risk management files (risk management plans, risk assessments, dFMEA, and risk management reporting). You will assist in the creation of verification and validation test plans, protocols and reports, while overseeing testing and analysis for standards and product requirements compliance. You will ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
- We are looking for a qualified person to Third Level Degree (BSc) in Mechanical Engineering or related discipline with 5 years' experience in a similar role.
- Good verbal and written communication skills including protocol / report development and technical presentations.
- You have experience Risk Management ISO 14971, and Experience of Process Validation (IQ, OQ, PQ), DOE, SPC and capability analysis. You have experience of design verification &validation test plan development and root cause failure analysis.
- You have a working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
- The following are desirable and not mandatory:
- You are familiar with the statistical software tools (Minitab, stat graphics, and statistical). You have knowledge of stability, biocompatibility, sterilization & ship testing knowledge. You have a DFSS / Lean Green Belt or Black Belt.
- You are familiar with IEC 60601, ISO 5361, ISO5366, and product specific industry standards. You will be open for travelling as part of the job (5-10% travel requirements) this position will be based out of Athlone with Global interfaces / support.
For further information on this Senior Quality Manufacturing Engineer role in Westmeath please contact Bimi Felix on 091730022 / email@example.com
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