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Rudhra Info Solutions - QMS Support - ISO

10 years

0 Lacs

hyderabad telangana india

Posted:4 weeks ago| Platform: Linkedin logo

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Skills Required

support management compliance audits audit drive training analyze data metrics risk analysis documentation manufacturing software verification testing

Work Mode

On-site

Job Type

Full Time

Job Description

QMS Support

Location : Hyderabad.Experience : 10+ Years.We are looking for highly experienced professionals to join our team as QMS Support.

Responsibilities

The ideal candidate will bring deep expertise in Quality Management Systems (QMS), regulatory frameworks, and compliance practices to ensure the highest quality standards in our Responsibilities :
  • Serve as the primary expert on Quality Management Systems (QMS), including ISO 9001 and other relevant standards.
  • Develop, implement, and maintain QMS policies, procedures, and documentation.
  • Lead internal & external audits; ensure audit readiness and drive corrective actions.
  • Collaborate with cross-functional teams to ensure compliance across departments.
  • Provide training & mentorship on QMS principles, tools, and best practices.
  • Analyze quality data & metrics to identify trends and areas for improvement.
  • Support risk management, CAPA processes, root cause analysis and participate in management review meetings.
  • Stay updated on regulatory changes and update QMS documentation Expertise :
In-depth knowledge of ISO 9001, ISO 13485, HIPAA, GxP, FDA regulations.

Strong Understanding Of

  • 21 CFR Part 11 & Part 21.
  • Good Manufacturing Practices (GMP).
  • CSV Regulations.
  • Software as a Medical Device (SaMD).
  • IEC 62304 & 82304 Regulations.
  • Verification Testing.
  • Penetration Testing & Join Us?
  • Work on impactful projects in a regulated environment.
  • Opportunity to collaborate with global teams.
(ref:hirist.tech)

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