Working within the Quality and Reliability Engineering Teams, analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing the reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, the facility of production, and availability of materials and equipment. Teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. Responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation, and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labour, as well as failure analysis, root cause, corrective action, and customer communication.
- Generate validation documentation (URS, IQ, OQ, PQ and process characterisation studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerised systems.
- Troubleshoot validation issues associated with the validation project and provide feedback to the product/process design team.
- Ensure consistency in validation/qualification approach across systems and projects. Review and approve changes to equipment, process, utilities, methods, and computerised systems to ensure the validation status of equipment is maintained.
- Ensure validation documents are up-to-date (primarily project MVPs and key inputs).
- Manage the execution of the product/process validation as per the MVP and project plan.
- Work directly with customer validation representatives to define inputs and requirements to the MVP.
- Ensure all results and data are correct and follow-up on any gaps or discrepancies.
- Liaise with the Engineering function to ensure that equipment validation requirements are maintained from Purchase to Qualification of new technology equipment.
- Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions.
- Maintain validation procedures and templates up to date, focusing on continuous improvement.
- Level 8 degree in Science/Engineering.
- 3+ years' experience in a similar role within the Medical Devices or related Healthcare industry.
- Strong knowledge of ISO and FDA quality requirements.
- Good understanding of validation concepts and documentation.
- Strong communication skills, including the ability to advise and influence.
- Excellent attention to detail and report-writing ability
- Proven ability to work on own initiative.
- Highly organized with a strong ability to prioritize tasks.
- General knowledge and experience of statistical analysis methods is an advantage.