Quality Management System Administrator (ISO 13485)

As a Quality Management System (QMS) Administrator specializing in ISO 13485, you will play a pivotal role in ensuring the effective implementation, maintenance, and continuous improvement of the Quality Management System within the organization. Your focus will be on compliance with ISO 13485 standards, and you will work closely with cross-functional teams to uphold and enhance quality processes.

General Responsibilities:

1. ISO 13485 Compliance: Oversee the implementation and maintenance of the Quality Management System in accordance with ISO 13485 standards.
   Ensure organizational compliance with regulatory requirements related to medical devices.
   
2. Documentation and Record Keeping: Develop, review, and update quality documentation, including procedures, manuals, and records.
   Maintain a comprehensive and up-to-date repository of quality records.
   
3. Internal Audits: Plan, conduct, and report on internal audits to assess compliance with ISO 13485 and identify areas for improvement.
   Collaborate with internal stakeholders to address audit findings and implement corrective and preventive actions.
   
4. Training and Awareness: Develop and deliver training programs on quality standards, procedures, and best practices.
   Foster a culture of quality awareness and continuous improvement among staff.
   
5. Change Management: Facilitate the change management process, ensuring that changes to the Quality Management System are effectively evaluated, approved, and implemented.
   
6. Risk Management: Support the identification, assessment, and mitigation of risks related to the QMS and product quality.
   
7. Supplier Quality Management: Collaborate with the procurement team to establish and maintain effective supplier quality management processes.
   
8. Regulatory Compliance: Stay abreast of changes in regulatory requirements and ensure that the QMS is adapted accordingly.
   

Functional Skills and Knowledge:

1. In-depth knowledge of ISO 13485 standards and regulatory requirements for medical devices.
2. Strong understanding of quality management principles and practices.
3. Experience in conducting internal audits and managing audit programs.
4. Proficient in document control and record-keeping procedures.
5. Familiarity with risk management processes within a medical device context.
6. Excellent communication and interpersonal skills.

Requirement:

• Bachelor's degree in a relevant field, such as Quality Management, Engineering, or a related discipline.
• Certification in Quality Management (e.g., Certified Quality Auditor) is a plus.
• Minimum of 2-3 years of experience in a similar role within the medical device industry, with a focus on ISO 13485 compliance.
• Proven ability to drive continuous improvement in quality processes.
• Strong problem-solving skills and attention to detail.
• Ability to work collaboratively with cross-functional teams.