Snr Quality Process Validation Eng

CAREERWISE RECRUITMENT

GALWAY

A Snr Quality Engineer for Process Validation is required by CareerWise Recruitment for our Galway based client on a 12 Month Contractor basis. At our Process Validation Department, we focus on providing process validation support during the full lifecycle of the product. From initial development of new products to ongoing support when products have been commercialized we ensure that the performance and safety of the devices we support is maintained through the product lifecycle. Please contact Tom Devaney for more information. THE ROLE: * As part of a cross-functional team, provide Quality Engineering technical direction/input to the product development process. * Provide expert QE technical direction/input to qualification and validation activities in conjunction with Engineering and extended QA teams. * Author and support (input and critical review) of qualification/validation protocols/reports. * Support the introduction/implementation of process/materials changes to the manufacturing operation. You will assess the impact on process validation for these changes. * Function effectively as part of cross functional teams; develop strong partnering relationships within these groups and provide constructive feedback and quality leadership. * Understand product construction, features and uses at a highly competent level to contribute to decision making process on product acceptance standards within their scope of responsibility. * Lead or support root cause investigations; drive problem solving efforts for quality issues. * Provide on-going communication, information transfer and record keeping in support of business and core-team objectives and metrics. REQUIREMENTS: * We are looking for a person qualified to Minimum of a Bachelor's degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science) and desirably with a minimum of 5 years relevant experience. * You are a dynamic team player, can work effectively and proactively on cross-functional teams. * Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions. * Knowledge of regulatory requirements and guidelines including 21 CFR parts 210, 211, 21 CFR part 820, ICH requirements and ISO 13485 requirements is necessary. * Knowledge of combination products, statistical requirements or software validation requirements an advantage. * You are a good communicator and fluent in English, both in writing and speaking. 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.

1393 days ago