3T Biosciences

QA/RA Manager

3T Biosciences

full-time

Posted on:

Location Type: Office

Location: Natick • Massachusetts • 🇺🇸 United States

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Salary

💰 $150,322 - $150,323 per year

Job Level

Mid-LevelSenior

About the role

  • 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
Soft skills
leadershipcommunicationorganizational skillscross-functional collaboration
Certifications
ISO 13485 certification
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