Quality Engineer II - Process Validation

At our Process Validation Department in Medtronic, Athlone, we focus on providing process validation support throughout 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 is maintained through the product lifecycle. This Senior Quality Engineer role will play a critical part in supporting new product introductions thus contributing to the global strategy and to deliver on our mission to contribute to human welfare by supporting the manufacture of products that alleviate pain, restore health, and extend life. Responsibilities may include the following and other duties may be assigned:

• Provide Quality and Process Validation Engineering input to the new product introduction process.
• Overseeing end‑to‑end validation activities to ensure processes, equipment, inspections and products meet regulatory, quality, and business requirements throughout the product lifecycle.
• Function effectively as part of cross functional teams; develop strong partnering relationships within these groups, collaborate and provide constructive feedback and quality/validation requirements.
• Author/review/approve/execute qualification/validation documentation and perform statistical analysis to ensure products meet the required standards and specifications.
• Provide online 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.
• Understands product construction, features and uses at a competent level to contribute to the decision-making process on product acceptance standards within their scope of responsibility.
• Complete test method validation for methods and procedures used for inspecting, testing and evaluating the precision and accuracy of products, test and production equipment.
• Ensure validation activities align with ISO 13485, FDA QSR, EU MDR, and internal quality systems requirements.
• Support regulatory and internal audits/inspections.
• Support root cause investigations; drive problem solving efforts for quality issues. Ensure 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.

• Minimum Level 8 bachelor's degree in a relevant Quality/Engineering/Science or related discipline.
• 3+ years relevant experience in a medical devices or similar regulated environment.
• Knowledgeable in Quality Systems, validation standards, policies, procedures and methodologies.
• Working Knowledge of plastic processing techniques such as Extrusion, Injection Moulding, Blow Moulding, Assembly is an advantage.
• Practical working knowledge of statistical data analysis and quality improvement tools and techniques is an advantage.
• A dynamic team-player and problem solver who can work effectively on cross-functional teams.
• Excellent organizational and time management skills and can prioritize and work effectively.
• Ability to multi-task and to take initiative is essential.