Mid - Level Quality Engineer at Boeing focusing on quality assurance and process improvement. Collaborating with various engineering functions to ensure compliance and improve overall quality performance.
About the role
- Quality Engineer responsible for leading quality assurance activities and compliance for medical devices. Collaborating across functions to uphold high standards of quality and regulatory compliance.
Responsibilities
- Maintain and improve the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, and other applicable standards.
- Act as the primary contact for quality issues, interfacing with internal teams and external stakeholders.
- Conduct risk assessments and develop risk management documentation, including FMEAs.
- Lead investigations into product non-conformances and complaints, performing root cause analysis and implementing CAPAs.
- Review and approve change requests, ensuring compliance with quality standards.
- Collaborate with cross-functional teams to drive quality improvements and product enhancements.
- Support internal and external audits, providing documentation and ensuring audit readiness.
- Analyze quality data to identify trends and opportunities for process improvements.
- Support product lifecycle activities from design to post-market surveillance, addressing product-related risks.
- Provide guidance and mentorship to entry-level technical staff.
- Interface with regulatory bodies and third-party auditors, such as FDA and Notified Bodies.
- Manage conflict resolution related to technical quality issues.
- Maintain all required training and seek continuous professional development.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
- 2-3 years of experience in quality engineering within a regulated industry, preferably medical devices.
- Proficiency in statistical analysis, quality tools, and methodologies (e.g., Six Sigma, FMEA).
- Strong understanding of medical device regulations (ISO 13485, 21 CFR 820, ISO 14971).
- Excellent communication skills, both verbal and written.
- Strong organizational skills with attention to detail and critical thinking.
- Project management experience and ability to work independently.
- Professional certification (e.g., ASQ, Six Sigma) preferred.
- Proficiency in Microsoft Office Suite.
Benefits
- Maintain compliance with safety policies and a safe work environment
Job title
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