Senior Quality Engineer

CAREERWISE RECRUITMENT

GALWAY

A Senior Quality Engineer for operations is required by CareerWise Recruitment for our Galway based client. People management, CAPA/Audit expert as well as Medical Devices experience essential. The Senior Operations Quality Engineer is a member of the Operations Quality group and is 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. * Lead and coordinate preparing & on-going maintenance of FMEAs and Control Plans. * 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. * Preparing and updating Operations procedures and associated documentation. * 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. * Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements. * Develop strong links with customer organisations and other project stakeholders. * 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. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

1521 days ago