Key Responsibilities:
Serve as the primary expert on Quality Management Systems, including ISO 9001 and other relevant standards.
Develop, implement, and maintain QMS policies, procedures, and documentation.
Lead internal and external audits; ensure audit readiness and follow-up on corrective actions.
Collaborate with cross-functional teams to ensure QMS compliance across departments.
In-depth knowledge of ISO 9001 and other quality standards.
Familiarity with regulatory requirements (e.g. FDA, ISO 13485, etc., if applicable).
Provide training and mentorship on QMS principles, tools, and best practices.
Analyze quality data and metrics to identify trends and areas for improvement.
Support risk management and root cause analysis for quality-related issues.
Stay updated on industry regulations and standards; ensure timely updates to QMS documentation.
Participate in quality reviews, CAPA processes, and management review meetings.
GXP Regulations
21CFR Part11 & Part 21 Regulations
HIPAA
ISO13485 Regulations
Verification Testing
Good Manufacturing Practice Regulations
CSV Regulations
Software as a medical device (SaMD)
IEC 62304 & 82304 Regulations
Penetration Testing, Security
About Virtusa
Teamwork, quality of life, professional and personal development: values that Virtusa is proud to embody. When you join us, you join a team of 27,000 people globally that cares about your growth — one that seeks to provide you with exciting projects, opportunities and work with state of the art technologies throughout your career with us.
Great minds, great potential: it all comes together at Virtusa. We value collaboration and the team environment of our company, and seek to provide great minds with a dynamic place to nurture new ideas and foster excellence.
Virtusa was founded on principles of equal opportunity for all, and so does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
