Quality Assurance Manager

As the Manager of Quality Assurance, you will be responsible for overseeing all aspects of the quality management system (QMS) to ensure the development, manufacturing, and clinical use of safe and effective cutting-edge cardiovascular medical devices. The QA Manager will work closely with cross-functional teams to maintain compliance with regulatory requirements and quality standards. This role requires an experienced leader with a deep understanding of medical device quality standards, including FDA regulations, ISO 13485, MDR, and other applicable industry guidelines.

Responsibilities

·       Quality Management System: Develop, implement, and maintain the company’s Quality Management System (QMS) to ensure compliance with FDA regulations (21 CFR Part 820), ISO 13485, MDR and other relevant international standards.

·       Product Lifecycle Management: Support product development teams through the product lifecycle, including design control, validation, and verification, ensuring adherence to established quality standards.

·       Manufacturing Support: Ensure production line compliance both in-house and at contract manufacturers.

·       Documentation and Audits: Responsible for creation and review of product documentation, including SOPs, work instructions, and validation protocols. Lead internal and external audits to assess the effectiveness of the QMS.

·       Supplier Quality Management: Collaborate with the supply chain and vendor management teams to ensure suppliers meet quality requirements and perform periodic audits of suppliers to maintain compliance.

·       Process Improvement: Lead continuous improvement initiatives to enhance the efficiency and effectiveness of quality processes, including risk management, CAPA (Corrective and Preventive Action), MRB (Material Review Board) and non-conformance investigations.

·       Quality Control: Lead and support Quality Control activities, including receiving inspections and final batch releases.

• ·       Risk Management: Act as the subject matter expert in risk management practices, including failure mode and effects analysis (FMEA), risk assessments, and ensuring proper documentation and mitigation strategies are in place.

Qualifications

•       Education: Bachelor or Master degree in Engineering, Life Sciences, or a related field.

•       Experience: Minimum of 7 years of experience in quality assurance within the medical device industry, preferably for cardiovascular implants, with at least 3 years in a leadership role.

•       Knowledge: In-depth knowledge of FDA regulations (21 CFR Part 820), ISO 13485, medical device industry standards, risk management, CAPA, and product lifecycle management.

•       Skills: Strong leadership, communication, and problem-solving skills. Ability to collaborate across departments to drive quality initiatives and improvements.

•     Strong proficiency in English (reading, writing, speaking)