Senior Quality Engineer - 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.

• Leading and 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 leadership.
• Develop device process validation strategy and provide expert QE technical direction/input to equipment qualification and validation activities.
• 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.
• Author and support qualification/validation plans and reports, performing statistical analysis to ensure products meet the required standards and specifications.
• Understands product construction, features and uses at a highly competent level to contribute to the decision-making process on product acceptance standards within their scope of responsibility.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• 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 by providing validation expertise and documentation.
• Mentor junior engineers and contribute to continuous improvement of validation standards and best practices.
• 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 engineering or science and desirably with 5-7 years of experience in Quality or Medical Devices.
• Significant experience in a Quality Engineering role with a strong validation focus, ideally in medical devices or another highly regulated industry.
• Demonstrated expertise in IQ/OQ/PQ, risk management, and equipment and validation lifecycle management.
• Practical working knowledge of statistical data analysis, problem solving and quality improvement tools and techniques.
• Ability to multi-task and to take initiative is essential.
• Strong interpersonal, communication and organizational skills.
• Excellent documentation, communication, and cross‑functional collaboration skills.