The Role
Develop, implement, and maintain the Quality Management System (QMS). Draft, review, and control SOPs, work instructions, and internal policies. Manage document control (versioning, approvals, archival), collaborate with cross-functional teams, and support continuous improvement of documentation and processes.
Summary Generated by Built In
We are looking for a QMS & Compliance Documentation Specialist to support the design, implementation, and maintenance of our Quality Management System (QMS), SOPs, and internal policies. This role is ideal for someone who enjoys hands-on documentation, process standardization, and ensuring organizational consistency.
Key Responsibilities
Required Skills & Qualifications
Preferred Qualifications
Experience in QMS software or document management systems (SharePoint, Confluence, or similar).
ISO Lead Implementer or Internal Auditor certification (nice-to-have).
Experience with process improvement or operational excellence within software industry.
Key Responsibilities
- Assist in developing and maintaining the QMS, ensuring documentation is accurate, up-to-date, and aligned with ISO-based standards.
- Draft, review, and update SOPs, work instructions, and internal policies across different departments.
- Support document control activities, including versioning, approvals, distribution, and archival of QMS and SOP documents.
- Collaborate with teams to ensure processes are clearly documented and aligned with internal standards.
- Participate in continuous improvement initiatives, suggesting enhancements to documentation quality, usability, and process consistency.
Required Skills & Qualifications
- Bachelor’s degree in Quality Management, Business Administration, Engineering, or related field.
- more than 10 years of experience in creating or maintaining QMS, SOPs, or internal policies.
- Strong skills in process documentation, SOP creation, and policy writing.
- Familiarity with ISO-based management systems (ISO 9001, ISO 27001, ISO 13485) and document control practices.
- Excellent written communication and attention to detail.
- Able to work independently and collaborate effectively with cross-functional teams.
Preferred Qualifications
Experience in QMS software or document management systems (SharePoint, Confluence, or similar).
ISO Lead Implementer or Internal Auditor certification (nice-to-have).
Experience with process improvement or operational excellence within software industry.
Skills Required
- Bachelor's degree in Quality Management, Business Administration, Engineering, or related field.
- More than 10 years of experience creating or maintaining QMS, SOPs, or internal policies.
- Strong skills in process documentation, SOP creation, and policy writing.
- Familiarity with ISO-based management systems (ISO 9001, ISO 27001, ISO 13485) and document control practices.
- Excellent written communication and attention to detail.
- Ability to work independently and collaborate effectively with cross-functional teams.
- Experience in QMS software or document management systems (SharePoint, Confluence, or similar).
- ISO Lead Implementer or Internal Auditor certification.
- Experience with process improvement or operational excellence within the software industry.
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The Company
What We Do
PaxeraHealth's mission is to democratize AI in medical imaging. Our Best in KLAS enterprise imaging platform delivers substantial improvements to the accuracy of diagnosis, ease of use and reducing physician burnout. Based in Boston, with a diverse employees and a wide range of backgrounds from 12 countries, we are passionate about revolutionizing medical imaging and saving lives. We are proudly managing more than 220 million imaging studies for 1500 customers in 45 countries. PaxeraHealth was recently recognized as one of the top 100 Healthcare technology companies by the Healthcare technology report.
