Quality Assurance Specialist
This role requires a Quality Assurance specialist to ensure the quality system is of the highest standard with a focus on validations and non-conformances.
* Implement and maintain quality systems to international standards, creating and reviewing documentation within the quality management system.
* Conduct internal audits to the ISO 13485 standard.
* Participate in customer and regulatory audits as required.
* Support product development, production trials, sampling, and production runs of new materials and finished products.
* Monitor vendors and issue NCMRs where necessary, ensuring problem vendors are identified and controls implemented.
* Report on relevant quality performance data and drive continuous improvement processes through change control activities.
* Manage investigations and closures of Validation Deviations, Non-conformances, and CAPAs, including supporting investigation processes when not the owner.
* Assist in generating and executing validation protocols and reports (IQ/OQ/PQ), including data analysis and test scripts as required.
A Bachelor's degree in Science, Engineering, or a related field is required, along with at least 3 years' experience working at a quality engineer level in an ISO 13485 regulated environment. Internal Auditor qualification to ISO 13485, experience with equipment validation, and statistical analysis are ideal. Strong interpersonal, problem-solving, and attention to detail skills are required.
Key Skills:
* Quality Engineer
* Quality Assurance
* Medical Device