Quality Management System - Medical Device

As a Quality Management System Specialist, you will play a critical role in ensuring the organization's adherence to established quality standards, procedures, and regulations. Your expertise will be instrumental in maintaining and improving our Quality Management System (QMS) to enhance operational efficiency, product quality, and customer satisfaction. You will collaborate with cross-functional teams to implement and monitor quality processes, drive continuous improvement, and contribute to the overall success of the organization.

Responsibilities:

QMS Development and Maintenance:

• Design, implement, and maintain the Quality Management System to comply with relevant industry standards, regulations, and best practices.
• Develop and update quality manuals, procedures, work instructions, and documentation to ensure alignment with organizational goals.

Process Improvement:

• Collaborate with teams to define and implement process improvements, reducing waste and enhancing overall quality.
• Identify areas for process optimization and efficiency enhancement within the QMS framework.

Quality Audits and Inspections:

• Plan, conduct, and lead internal and external quality audits to assess compliance with QMS requirements.
• Coordinate responses to audit findings and work with teams to implement corrective and preventive actions.

Training and Education:

• Foster a culture of quality awareness and responsibility across the organization.
• Provide training to employees on QMS principles, procedures, and standards to ensure consistent understanding and implementation.

Documentation and Reporting:

• Maintain accurate and up-to-date records of quality-related activities, including audit reports, corrective actions, and performance metrics.
• Generate regular reports and metrics to communicate the effectiveness of the QMS to management.

Risk Management:

• Identify potential quality risks and collaborate with relevant teams to develop risk mitigation strategies.
• Ensure that appropriate controls are in place to manage and minimize potential quality-related risks.

Regulatory Compliance:

• Stay updated on industry regulations and standards to ensure the organization's continued compliance.
• Support the preparation of documentation for regulatory submissions and approvals.

Continuous Improvement:

• Participate in continuous improvement initiatives and projects to enhance product quality, operational efficiency, and customer satisfaction.

Qualifications:

• Strong understanding of quality management principles, methodologies, and best practices.
• Excellent communication, interpersonal, and problem-solving skills.
• Bachelor's degree in a relevant field (Quality Management, Engineering, Life Sciences, etc.).
• Ability to work collaboratively in cross-functional teams and lead quality improvement efforts.
• Professional certifications related to quality management (e.g., ASQ Certified Quality Auditor, Certified Quality Manager) are a plus.
• Familiarity with relevant industry regulations (e.g., ISO 9001, FDA regulations) is preferred.
• Proficiency in using quality management tools and software.
• Proven experience in quality management, quality assurance, or regulatory compliance roles.
• Attention to detail and a commitment to maintaining high standards of quality.

Join our team and make a meaningful impact on our commitment to delivering high-quality products/services while upholding the highest standards of quality and compliance.