Quality Assurance Specialist

At Equashield, we are pioneers in hazardous drug safety, revolutionizing the way healthcare providers handle and administer medication with best-in-class CSTD & pharmacy Automation through Robotics. We are looking for a Quality Management System (QMS) Specialist.

Job Description:

Responsible for the establishment, development, and maintenance of the Quality Management System (QMS) in accordance with QMSR and ISO 13485 requirements. The role includes developing, implementing, and updating company procedures to ensure compliance with QMSR and ISO 13485 standards. The specialist will provide professional quality support to R&D and production projects, oversee design control processes per regulatory requirements, and collaborate with cross-functional teams to ensure full compliance with all applicable standards.

Responsibilities

• Establish, develop, and maintain the organization’s QMS in compliance with QMSR and ISO 13485 requirements.
• Develop, implement, and regularly update procedures and work instructions according to QMSR and ISO 13485 standards.
• Provide professional quality support for R&D and production projects to ensure adherence to quality requirements.
• Manage and monitor design control processes in accordance with regulatory standards.
• Collaborate closely with engineering, development, regulatory, and quality teams to ensure compliance with all relevant standards and regulations.

Requirements

• Relevant academic degree in a related field.
• Minimum of 3 years of experience in quality assurance, with a focus on writing procedures – mandatory.
• High proficiency in English, both written and verbal, including technical writing – mandatory.
• Experience with document management systems (ALM, PLM) – advantage.