Quality Engineer ll
hace 2 semanas
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-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.
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