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Quality Engineer
4 months ago
Please apply or send your resume to klelix.hamlin@lumicity.io
The Quality Engineer is responsible for overseeing the quality assurance of medical devices, from initial design through manufacturing and post-market surveillance. This role ensures that all products are manufactured in compliance with ISO 13485, FDA, and other regulatory standards.
**Essential Duties and Responsibilities:**
- **Quality System Management:**
- Maintain and improve the Quality Management System (QMS) in accordance with ISO 13485 and FDA regulations.
- Participate in internal and external audits, including preparing necessary documentation and follow-up on corrective actions.
- **Validation and Verification:**
- Design and execute validation protocols for new products and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Ensure all manufacturing processes, equipment, and materials meet pre-set quality standards.
- **Risk Management:**
- Conduct risk analysis and management throughout the product lifecycle in accordance with ISO 14971.
- Prepare and maintain Risk Management Files (RMF) for all products.
- **Product Quality Assurance:**
- Perform root cause analysis on product failures and implement corrective and preventive actions (CAPA).
- Review and approve product testing methods and final product releases.
- **Supplier Quality Management:**
- Work with suppliers to establish quality requirements for materials, components, and sub-assemblies.
- Conduct supplier audits and performance evaluations to ensure compliance with quality standards.
- **Documentation and Reporting:**
- Develop and maintain comprehensive documentation for quality assurance processes and procedures.
- Generate quality reports for management review, including trend analysis and quality performance metrics.
- **Training and Leadership:**
- Train and support production staff on quality assurance standards and practices.
- Lead cross-functional teams to address and resolve quality issues.
**Qualifications:**
- Bachelor's degree in Engineering, Quality, or a related field.
- 3+ years of experience in quality engineering within the medical device industry.
- Strong understanding of FDA, ISO 13485, and other regulatory standards.
- Proficiency in statistical analysis software and Microsoft Office Suite.
- Excellent communication and interpersonal skills.
- Strong analytical and problem-solving abilities.
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