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QMS Executive

2 months ago

Bengaluru, India Fourth Frontier Full time

Position Summary:

 

We are seeking a motivated and detail-oriented Quality Management System (QMS) Executive to join our team. As a QMS Executive, you will assist in the development, implementation, and maintenance of our Quality Management System to ensure compliance with regulatory standards and continuous improvement in quality processes.

 

Responsibilities:

 

● Assist in documenting and updating standard operating procedures (SOPs) related to quality management.

● Support in the preparation and execution of internal audits to assess compliance with QMS requirements.

● Engage in relevant QMS IS discussions.

● Help analyze audit findings and assist in developing corrective and preventive action plans (CAPA).

● Collaborate with cross-functional teams to ensure adherence to quality standards and regulatory requirements.

● Participate in quality improvement initiatives and projects.

● Ensure QMS reflects actual activities, business needs and supports NPD requirements.

● Support the function with adequate data and trends

● Ensure Standard Operating Procedures remain current and reflect the needs of the business

● Oversee and execute development and/or modification of Fourth Frontier QMS.

● Contribute to the review and updating of quality documentation and records.

● Perform other duties and cross-training as assigned.

● Assist in training employees on quality procedures and policies.

 

Requirements:

● 0-2 years of experience

● Bachelor’s degree in a Science, Engineering, Business or related discipline.

● Knowledge or coursework related to Quality Management Systems (ISO 13485, FDA regulations, etc.) is preferred.

● Strong attention to detail and organisational skills.

● Excellent communication and interpersonal skills.

● Ability to work independently and collaboratively in a team environment.

● Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)

 

Desirable Criteria:

● Experience in a regulated environment and interaction with regulatory agencies required.

● Some knowledge and understanding of US regs (21 CFR Part 820) and ISO 13485

● Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)

● Strong communication, project management and influencing skills.

● Attention to detail Computer literacy

● Some travel may be required