Quality Assurance Specialist
As a Quality Assurance Specialist, you will play a crucial role in maintaining and enhancing quality systems within a regulated environment. Your key responsibilities will include ensuring compliance, driving continuous improvement, and supporting product development in a dynamic setting.
Key Responsibilities:
* Maintain and improve quality systems aligned with ISO 13485 and ISO 9001 standards.
* Develop and revise standard operating procedures (SOPs) and quality documentation.
* Conduct internal audits to ISO 13485 standards.
* Participate in customer and regulatory audits.
* Support new product development, including trials, sampling, and production runs.
* Monitor vendor performance and implement controls to protect product integrity.
* Report on quality performance metrics and lead change control initiatives.
* Investigate and close validation deviations, non-conformances, and corrective action plans.
* Assist in the creation and execution of validation protocols (IQ/OQ/PQ), including data analysis and test scripting.
Successful candidates will have a bachelor's degree in science, engineering, or a related field, along with a minimum of three years' experience as a Quality Engineer in an ISO 13485 regulated environment. Certification as an internal auditor to ISO 13485 is also required. Additionally, proven experience in equipment validation and statistical analysis is highly valued.