Job Title: Quality Assurance Specialist
Role Overview:
* This role ensures product quality from early development phases through to commercialization.
Responsibilities:
* Comply with policies and procedures, as well as national and international regulations.
* Lead compliance and improvement activities for the quality system.
* Apply systematic problem-solving methods to identify, prioritize, communicate, and resolve quality issues.
* Plan, execute, report, and follow up on quality audits.
* Provide expertise in quality assurance and controls to develop and improve the company's quality management system.
* Develop control plans, inspection plans, and testing strategies to ensure product compliance.
* Collaborate with suppliers to establish robust quality agreements.
* Collect and analyze data to support statistical rational sample testing requirements.
Requirements:
* Bachelor's degree in engineering or a related technical field.
* Minimum of 3 years' experience in quality assurance within the medical device industry.
* Strong understanding of basic engineering principles.