QMS Compliance Specialist
First seen by Alion on Sep 1, 2026.
QMS Compliance Specialist
Experience: 8 - 13 Years
Education: Bachelors Degree in Engineering preferred (B.Tech/B.E. preferred)
Availability: Immediate joiner/ less then 15 days
Required Qualifications:
- 8 - 13 years of overall professional experience, with strong experience in Quality Management Systems/QMS administration or compliance.
- Bachelors degree in Engineering preferred; B.Tech/B.E. strongly preferred. Other relevant bachelors degrees may be considered.
- 5 - 8+ years of hands-on QMS experience in a regulated environment.
- Strong knowledge of ISO 13485 and FDA regulations, particularly 21 CFR Part 820/QMSR.
- Experience performing QMS gap assessments, compliance assessments, and remediation activities.
- Experience creating or updating SOPs, work instructions, quality records, and controlled documentation.
- Experience with CAPA, change control, risk management, and quality metrics.
- Experience supporting QMS integration, harmonization, or process standardization across sites or organizations.
- Exposure to eQMS implementation, migration, validation, or system consolidation.
- Strong understanding of data integrity, document traceability, and quality-system controls.
- Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.
- Experience with SharePoint is preferred.
- Strong analytical, problem-solving, communication, and stakeholder-management skills.
- Ability to work independently and effectively with limited supervision.
- Self-starter with the ability to identify opportunities, investigate issues, and recommend practical solutions.
Skills
QMS, IT Compliance, Quality, Capacity And Availability Management, ISO