We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
As part of a cross-functional team, provide Quality Engineering input to the product development process and the execution of technology transfer plans.
• Provide on line support during design and/or validation builds with emphasis on production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Provide QE support to qualification and validation activities in conjunction with Engineering and extended QA teams to ensure quality standards are in place.
• Author and support qualification/validation protocols and reports.
• Complete test method validation for methods and procedures used for inspecting, testing and evaluating the precision and accuracy of products, test and production equipment
• Support the introduction/implementation of process/materials/supplier 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.
• Support root cause investigations; drive problem solving efforts for quality issues. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
• Provide on-going communication, information transfer and record keeping in support of business and core-team objectives and metrics.
KEY SKILLS & EXPERIENCE
• 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 2 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 an advantage.
• Knowledge of combination products, statistical requirements or software validation requirements is an advantage.
• You are a good communicator and fluent in English, both in writing and speaking.