· 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-C1

EXPERIENCE:

· 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.

ADDITIONAL SKILLS:

· Ability developing and/or facilitating 1st article inspection, and/or Supplier Quality.

· 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.