Senior Quality Engineer

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Title: Senior Quality Engineer - OperationsLocation; Parkmore, GalwayBenefits: Excellent career progression, negotiable salary, pension, healthcare and yearly bonus. Company: My client is ranked among the top 10 global companies in the medical device outsourcing industry, they specialize in the design and manufacture of minimally invasive delivery and access devices for a range of therapies. Headquartered in Galway, they has a global operational footprint with design and manufacturing facilities spanning the U.S., South America, Europe and Asia. Job Overview: Reporting to the Quality Manager, the Senior Operations Quality Engineer is a member of the Operations Quality group. The successful candidate will be responsible for Operations Quality within their prescribed area of functional responsibility. You will lead and work as part of a team to maintain high quality/performance standards on all Medical products Responsibilities:Deliver on all KPIs that help the business achieve its goal.Lead and drive QA initiatives within area of functional responsibility.Provide Quality input and support to the Manufacturing, Engineering, Prototype and Commercial functions.Lead, coordinate & maintain risk assessment documentation e.g. FMEA's.Investigate root cause of Quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues. Strategically lead new product introduction and contract reviews from a QA perspective.Prepare and updating Operations procedures and associated documentation.Overall responsibility for functional area GMP standards and compliance including the promotion of Quality awareness.Establish inspection standards, sampling plans, and test methods..Develop strong links with customer organisations and other project stakeholders. Quality review of functional area validation documentation.Perform and support internal and external audits to ISO and FDA requirements.Perform an active role in further development and continuous improvement of the Quality Management system.Supervision and direction of Quality personnel.Requirements:Clear understanding medical device quality systems and requirements, including measurement techniques, would be a distinct advantage.Strong CAPA experience.Strong root cause analytical and problem-solving skills. Strong working knowledge of FDA and ISO Quality systems for Medical device companies desirable.Supervisory experience desirable.Qualifications:Level 8 degree in Science / Engineering or related fields. Minimum of 5 years industry experience in a medical device manufacturing environment.If you are interested in applying or hearing more about my client and this position forward your up to date CV and we can have a call to discuss further. Looking forward to hearing from you. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales