Quality Management Systems (QMS) and Cybersecurity Compliance Specialist

Job Description:

Seeking a skilled Quality Management Systems (QMS) and Cybersecurity Compliance Specialist to lead the integration and upgrade of our QMS, assist in internal cybersecurity audits, and provide regulatory submission support (FDA, EU) at our Boston site. The ideal candidate will bring a comprehensive understanding of quality management processes, document control, and corrective and preventive actions (CAPA), with experience supporting regulatory compliance initiatives.

Key Responsibilities:

1. QMS Integration and Upgrade:
   • Drive the integration and upgrade of QMS to align with FDA and EU regulatory standards.
   • Maintain documentation processes, ensuring accuracy, accessibility, and regulatory compliance.
   • Develop, implement, and refine QMS procedures, workflows, and best practices to meet regulatory and industry standards.
2. Cybersecurity Audit Support:
   • Assist in cybersecurity compliance and internal audits, ensuring QMS alignment with cybersecurity standards.
   • Collaborate with the cybersecurity team to address findings and implement corrective actions.
3. Regulatory Submission Support:
   • Provide detailed support for FDA and EU regulatory submissions, working closely with the regulatory affairs team.
   • Compile, review, and verify regulatory documentation to ensure compliance with submission standards.
4. Document Control and Quality Process Specialist:
   • Manage document control activities, including creation, review, and approval workflows.
   • Ensure records are maintained in accordance with internal policies and regulatory requirements.
5. CAPA Management:
   • Lead corrective and preventive action (CAPA) processes, from root cause analysis to resolution and verification.
   • Track and report CAPA activities, ensuring timely and compliant closure.
6. Quality Assurance and Compliance:
   • Support continuous improvement in quality assurance by identifying process gaps and implementing corrective measures.
   • Serve as a subject matter expert for regulatory compliance, providing guidance to teams on quality standards and best practices.

Qualifications:

• Bachelor's degree in Quality Management, Regulatory Affairs, Life Sciences, or a related field.
• Minimum of 5 years of experience in QMS, quality assurance, regulatory compliance, or related roles.
• Software/AI experience.
• Strong knowledge of FDA and EU regulatory requirements, specifically with QMS.
• Experience with CAPA processes, document management, and regulatory submissions.
• Familiarity with cybersecurity audit procedures and standards.
• Excellent communication skills, with a keen attention to detail and ability to manage multiple priorities.

Preferred Qualifications:

• Certification in Quality Management or Regulatory Affairs (e.g., ASQ, RAPS).
• Hands-on experience with QMS software systems.
• Experience in the medical device or healthcare tech industry.