QMS Specialist

Overview

The QMS Specialist supports the establishment of a compliant and effective Quality Management System for the activities in scope, working under general supervision and collaborating with cross-functional teams to resolve quality issues.

What you'll do

• Participate in developing and revising QMS process documents, such as SOPs and quality manuals, ensuring their accuracy and currency.
• Collect, compile and report data on QMS performance metrics, such as non-conformances, critical findings and training completion rates, to support management decision-making.
• Track non-conformance reports and contribute to continuous improvement initiatives to enhance efficiency and compliance within existing QMS processes.
• Participate in the planning and organization of internal audits, prepare necessary documentation, assist audit teams during audits, and ensure follow-up actions are completed.
• Ensure proper maintenance, organization and archiving of quality records in accordance with QMS procedures, regulatory requirements and company policies to maintain audit readiness.
• Collaborate with cross-functional teams and stakeholders to communicate and explain QMS processes and provide basic guidance on compliance-related inquiries.
• Participate in problem-solving sessions by providing data and insights on quality processes, supporting root cause identification and recommending potential corrective actions.
• Engage in risk management activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and proposing mitigation strategies.
• Participate in training sessions to stay updated on quality standards, QMS procedures, industry regulations and best practices.
• Apply comprehensive knowledge of company products and services to effectively address challenges and opportunities.

What you'll need

• 6–10 years of experience; mid-level professional.
• Strong experience in document control and QMS documentation, including use of PLM and electronic document management systems such as Windchill.
• Experience managing controlled documents, revisions, approvals and change workflows.
• Experience maintaining device master record (DMR) or equivalent product documentation files.
• Good understanding of QMS standards and regulations, including ISO 13485, FDA QMSR and EU MDR.
• Experience with QMS processes such as training and participation in internal and external audits.
• Bachelor of Engineering and/or MSc (Science, Biomedical, Biotech, etc.).
• Regulatory requirements, Quality Management Systems (QMS), troubleshooting, KPI monitoring and reporting, data analysis and interpretation, process improvements, Agile methodology, user training and support, training content development, business acumen.

Details

• Location: Bangalore.
• Works under general supervision and established processes.
• Office-based teams work in-person at least 3 days per week.