QMS Specialist

Job Title

Job title:

QMS Specialist

Your role:

• Takes ownership of Quality processes to ensure that QMS is efficient and meets the regulatory requirements.
• Analyzes QMS metrics and performance indicators, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management.
• Works under limited supervision and broad guidelines, regularly applying independent judgment on matters of significance to drive project success and compliance.
• Contributes to the development, implementation, and revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards.
• Conducts risk assessments activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and developing robust mitigation strategies to minimize their impact.
• Participates in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence.
• Applies specialized knowledge in breadth and/or depth to a variety of issues and projects within the team, ensuring effective solutions and innovative approaches to complex challenges.
• Cultivates effective relationships with internal and external partners, providing influence over projects and peer groups by demonstrating a comprehensive understanding of the area of specialization.
• Leads cross-functional problem-solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions.
• Coordinate, prepare for and participate in external and internal regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders.
  

You're the right fit if:

• Experience- 12+years of experience in QMS specially in MEDtech industry
• Skills-
• Regulatory Requirements
• Audit Management
• Quality Management Systems (QMS)
• Project Management
• Data Analysis & Interpretation
• Process Improvements
• Technical Writing
• Agile Methodology
• Training Content Development
• Business Acumen
• Education- bachelor's degree in any Engineering
• Anything else- Good Communication skills, lead and front face the important Audit & Inspection.
  

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