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.
REQUIREMENTS
EDUCATION:
Bachelor´s degree in Industrial Engineer or any other related area.
Working knowledge of the quality system regulation (21CFR PART 820) and ISO 13485 requirements. (desirable).
Yellow or Green Belt certification (desirable).
English B2.
EXPERIENCE:
At least 1 year 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.
ADDITIONAL SKILLS:
Ability to develop technical investigations.
Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to write speeches and articles for publication that conform to prescribed style and format.
Ability to effectively present information to top management, public groups and/or boards of directors.
Ability to maintain a professional manner and appearance.