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.