Junior Quality Engineer
full-time•San José
About this role
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
EDUCATION:
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.
- Research 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. - Yellow or Green Belt certification (desirable).
- English B2.
- Previous experience in Quality in a regulated industry.
- Preferred: Knowledge of statistical analysis tools and familiarity with equipment and process validation.
- Familiarity with Minitab or any equivalent statistical tool is required.
Other facts
Tech stack
Quality Control,Documentation Management,Root Cause Analysis,Corrective Action,Preventive Action,Statistical Analysis,Inspection,Quality Management Systems,FDA Regulations,ISO Standards,Continuous Improvement,Lean Manufacturing,Test Equipment,Quality Data Analysis,Internal Audits,Supplier Audits
About Theragenics Costa Rica Ltd.
At Theragenics, we’re dedicated to empowering the fight against cancer and other diseases by producing innovative medical radioisotopes. These vital materials form the foundation of radiopharmaceuticals and LDR brachytherapy treatments, offering patients minimally invasive and targeted options.
Since 1981, we have been at the forefront of radioisotope production, continually pushing boundaries to advance cancer care. Our unwavering dedication to the healthcare community ensures a reliable supply to meet your needs. Through strong partnerships, we strive for optimal patient outcomes. Partner with Theragenics to access the vital radioisotopes vital for life-saving treatments.
Team size: 501-1,000 employees
Website: http://www.theragenics.com
LinkedIn: Visit
Industry: Medical Device
Founding Year: 1981
What you'll do
- The Junior Quality Engineer will support the Quality Assurance team by managing quality control processes and documentation. They will also participate in inspections, tests, and continuous improvement initiatives to ensure product quality and regulatory compliance.
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Frequently Asked Questions
What does a Junior Quality Engineer do at Theragenics Costa Rica Ltd.?
As a Junior Quality Engineer at Theragenics Costa Rica Ltd., you will: the Junior Quality Engineer will support the Quality Assurance team by managing quality control processes and documentation. They will also participate in inspections, tests, and continuous improvement initiatives to ensure product quality and regulatory compliance..
Why join Theragenics Costa Rica Ltd. as a Junior Quality Engineer?
Theragenics Costa Rica Ltd. is a leading Medical Device company.
Is the Junior Quality Engineer position at Theragenics Costa Rica Ltd. remote?
The Junior Quality Engineer position at Theragenics Costa Rica Ltd. is based in San José, Alajuela Province, Costa Rica. Contact the company through Clera for specific work arrangement details.
How do I apply for the Junior Quality Engineer position at Theragenics Costa Rica Ltd.?
You can apply for the Junior Quality Engineer position at Theragenics Costa Rica Ltd. directly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process. You can also learn more about Theragenics Costa Rica Ltd. on their website.