Junior Quality Engineer in Alajuela, Alajuela at Theragenics Corp

PURPOSE OF JOB

The Junior Quality Engineer will assist the Quality Assurance team by supporting quality control processes, managing documentation, and addressing issues to ensure product quality and regulatory compliance throughout the entire product lifecycle. This role will also involve participating in the development and implementation of quality procedures, conducting inspections and tests, and contributing to continuous improvement initiatives to enhance product performance and reliability.

RESPONSABILITIES

• Provide manufacturing on-the-line Quality support.
• Assist in the development, implementation, and maintenance of quality management systems (QMS) in accordance with FDA, ISO, and other relevant regulations and standards.
• Support the execution of quality control tests and inspections to ensure products meet specified quality standards.
• Participate in root cause analysis and corrective/preventive action (CAPA) processes to address quality issues and non-conformities.
• Analyze and review the performance and outcomes of current inspection activities to ensure they effectively detect and address quality issues.
• Support and assess the suitability of inspection gauges, test equipment, and technology for specific quality control needs.
• Evaluate the performance, accuracy, and reliability of existing and potential inspection tools and equipment.
• Document and maintain quality records, including test results, inspection reports, and compliance documentation.
• Assist in conducting internal and supplier audits to assess compliance with quality standards and regulatory requirements.
• Contribute to the development and revision of quality procedures, work instructions, and standard operating procedures (SOPs).
• Analyze quality data and metrics to identify trends, areas for improvement, and potential risks.
• Provide support during external audits and inspections.
• Stay updated on industry trends, regulations, and best practices related to medical device quality assurance.
• Engage in continuous improvement projects aimed at enhancing product quality, safety, and process efficiency.
• Support the implementation of lean manufacturing principles and quality improvement strategies.

EDUCATION:

• Bachelor´s degree from four-year college, university, or 1 year related experience, and/or training or equivalent combination of education and experience.
• Working knowledge of the quality system regulation (21CFR PART 820) and ISO 13485 requirements.
• English B2/C1

EXPERIENCE:

• Previous experience in Quality in a regulated industry. (Desirable)
• Familiarity with Minitab or any equivalent statistical tool is required.
• Preferred: Knowledge of statistical analysis tools and familiarity with equipment and process validation.