Serve as the QA/RA Lead in cross-functional development projects
Develop, manage and maintain the documentation systems
Develop quality system procedures, instructions and forms throughout process
Own the core quality system processes
Oversee training, develop, and deliver training for Quality Management System processes
Generate metrics for critical-to-quality process
Participate and drive quality process improvement initiatives and project teams
Assist in establishing processes and procedures to enable international entry
Review and approve internal CAPAs, Change Controls, Deviations and other quality processes
Requirements
Masters Degree in Bioengineering, Industrial Engineering or a closely-related field
Three (3) years of quality assurance experience
Minimum one (1) year working in ISO 13485 certified or FDA regulated environment
Must be ISO 13485 certified in minimum of two management systems competencies
On-site availability Monday - Friday from 8:30am - 5:00pm in Natick, MA
Relocation support is not available for this role
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality assurancedocumentation systems managementquality system procedures developmentmetrics generationprocess improvementtraining developmentCAPA reviewChange Control reviewDeviation review