As a Quality Assurance Specialist, you will be responsible for ensuring the highest standard of quality in our organization. Your focus will be on validations and non-conformances, working closely with cross-functional teams to drive continuous improvement.
Key Responsibilities:
* Implement and maintain a quality system that meets international standards, including ISO 13485 and ISO 9001.
* Carry out internal audits to ensure compliance with regulatory requirements.
* Participate in customer and regulatory audits as required.
* Support product development, production trials, and sampling.
* Monitor vendors and issue notifications where necessary.
* Report on quality performance data and drive continuous improvement processes.
* Manage investigations and closure of validation deviations, non-conformances, and corrective actions.
* Assist with validation protocols, reports, and data analysis.
Requirements:
* Bachelor's Degree in Science, Engineering, or a related field.
* Minimum 3 years' experience in a quality engineer role in an ISO 13485 regulated environment.
* Internal Auditor qualification to ISO 13485 is preferred.
* Experience with equipment validation and statistical analysis is essential.
* Strong interpersonal, problem-solving, and attention to detail skills.