Senior Quality Engineer

Careerwise Recruitment

Galway

A Senior Quality Engineer for Operations, required by CareerWise Recruitment for our Galway based client.Senior Quality Engineerwill be responsible for Operations Quality within their prescribed area of functional responsibility. The successful candidate will lead and work as part of a team to maintain high quality / performance standards on all products.Reporting to the Operations Quality Manager, the position will be challenging and will require an ability to lead a team and work on own initiative and with minimum supervision. Please contact Tom Devaney for more information. THE ROLE: * Lead and drive QA initiatives within area of functional responsibility. * Provide quality input and support to the manufacturing, engineering, prototype and commercial functions. * Investigating 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. * Overall responsibility for functional area GMP standards and compliance including the promotion of Quality Awareness. * Establishing inspection standards, plans, frequencies and test methods. * Reporting functional are Quality metrics. * Preparation of Quality reports for Operations meetings and management reviews. * Understanding of standard metrology good practice. * Quality review of functional area validation documentation. * Performing and supporting internal and external audits to ISO and FDA requirements. * Performing an active role in further development and continuous improvement of the quality management system. * Support Operations area projects and initiatives i.e. Kaizen, CFPS etc. * Supervision and direction of Quality personnel. * Other tasks as directed by the Operations Quality Manager in line with company goals and objectives. REQUIREMENTS: * Degree in Science / Engineering or related fields essential. * Minimum of 5yrs industry experience in a medical device-manufacturing environment. * 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. * New product introduction and manufacturing process transfer experience desirable. * Demonstrated excellent organizational skills and ability to work on own initiative essential. * Supervisory experience desirable. * Excellent written and verbal communication skills essential. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. CareerWise Recruitment. In Search of Excellence. We provide recruitment services in the areas of Engineering, Supply Chain, Sciences, IT and Accounting & Finance. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. This job originally appeared on RecruitIreland.com.

2250 days ago