Quality Engineer

Position Summary

As a Quality Engineer you will be responsible for planning and executing activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

With the use of statistical techniques and other quality principles, you will support complaint/CAPA investigations, supplier quality improvement as well as develop and maintain metric systems.

Duties

• Comprehensive knowledge of quality management system, risk assessment, and validation practices to support compliance for site and business strategy.
• Act as the Quality lead and interface externally & internally with customers to define requirements, communicate progress, identify solutions to Quality issues, and demonstrate applied knowledge.
• Manage and communicate the status of projects for Quality: prepare project plans, determine timelines and resources, present and effectively communicate information and progress to cross-functional teams and management.
• Ensure management of changes associated with products and processes is carried out appropriately using science and risk-based assessment to determine impact of change.
• Assist in ensuring that current compliance issues and trends, both internal and site impacted, are critically evaluated and training is provided where appropriate.
• Analyze and maintain metric systems to provide feedback on Quality performance.
• Works with departmental managers to evaluate training needs and supports effective learning interventions to ensure critical training requirements are provided to support compliance.

Duties - cont'd

• Responsible for coordinating internal audit schedules and liaising with technical management to ensure that all corrective actions are executed timely and that the quality in the respective business units meet the required international standards as outlined in the Quality Manual.
• Support the site in the management of process improvements, technical developments in order to increase operational efficiencies and maximize output.
• Initiate and drive Continuous Improvement programs, attentive to detail and accuracy, is committed to excellence, looks for improvement continuously, monitors quality levels, finds root cause of quality problems, owns/ acts on quality problems.
• Remains up to date with INAB policy requirements, including change notification requirements.
• Ensure the vendor appraisal process, validation, calibration and maintenance activities are effective and documented in a compliant manner. Support all external audits regulatory. agencies/customers as required.
• Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
• Ensure compliance with safety procedures at all times.

Education Degree

Required Experience

• Experienced Internal Auditor – minimum one-year experience internal and lead auditor
• Strong understanding of QMS, NC/CAPA necessary key elements
• Experience working within a regulated industry – minimum two years
• Ability to interact and influence at all levels within the organization.
• Strong problem-solving ability.
• Good communicator both verbally and in writing.
• High level of attention to detail and accuracy.
• Strong organizational skills.
• Ability to manage and deliver multiple projects in an effective and confident manner.
• Demonstrated ability in facilitating or managing projects in a self-directed and dynamic manner.
• Ability to work closely with various levels of the organisation to ensure quality requirements are achieved.
• Good interpersonal skills.
• Knowledge of MS Office applications, including Word and Excel.