JOB OPERATION/ELEMENTS

Responsibilities

• 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.
• Must be organized and detail oriented.