Senior Quality Engineer (Operations)

CAREERWISE RECRUITMENT

GALWAY

A Senior Quality Engineer (Operations) is required by CareerWise Recruitment for our Galway based client. 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. They 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. The focus of the role is to supply high-quality medical devices and components to deliver an Extraordinary Customer Experience. Please contact Tom Devaney for more information. THE ROLE: * Manage the day to day activities of the team in a safe environment and be responsible for Health and Safety goals. * Supervision and direction of Quality personnel. * 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. * Report Quality metrics. * 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. REQUIREMENTS: * Level 8 Degree in Science / Engineering or related fields. * Minimum of 5 years 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.

1352 days ago