QMS Specialist

Job title:

QMS Specialist

Your Role

• Provides oversight for issuance and review of QMS documents, ensuring meticulous tracking and documentation of all changes, upholding the highest standards of system integrity and accuracy, and aligning QMS practices with organizational goals.
• Participates in the effective deployment and continuous improvement of QMS processes.
• Collaborates with cross-functional teams and stakeholders to ensure effective communication and understanding of QMS processes, and provide basic guidance on compliance-related inquiries.
• Updates and support update to QMS documents to maintain QMS integrity and consistency.
• Develops professional expertise and applies comprehensive knowledge of QMS requirements to effectively address challenges and opportunities.
• Participates in the enhancement of review and approval process for new and revised QMS documents, ensuring alignment with company standards and regulatory requirements.
• Provides support during internal and external audits and inspections by assisting with the preparation of documentation, ensuring document compliance with quality standards, responding to basic audit queries, and coordinating the implementation of corrective actions related to QMS control.
• Conducts assessments related to QMS control activities, identifying potential issues and implementing mitigation strategies to ensure the integrity and security of all records.
• Implements and manages QMS control software updates and upgrades, ensuring minimal disruption and compliance with the latest standards.
• Works under general supervision and established processes, utilizing independent judgment to navigate and adhere to operational procedures, ensuring compliance and optimal performance.
• Resolves medium complexity requests efficiently, exercising judgment within defined procedures and practices to determine appropriate actions that align with organizational goals and objectives.
• Establishes productive internal and external working relationships to resolve mutual problems, collaborating effectively to ensure smooth operations and achieve common goals.
• Engages in ongoing training and development programs to expand knowledge and skills related to document control and quality management systems, staying abreast of industry standards and regulatory compliance.
  

You're the right fit if:

• Experience- 5+yrs of experience in Medtech industry
• Skills- Electronic Document Control and Management advantage for experience in Regulatory Requirements (design or production), Quality Management Systems (QMS), Troubleshooting, Process Improvements
• Education- Bachelor's Degree in Mechanical/ Electrical Engineering, IT, Industrial Engineering, Science or equivalent
• Anything else- Team work, work in multicultural environment, vigilance, diligence, Strong written and verbal communication skills.
  

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