Director, Quality Assurance

Job Title: Director, Quality Assurance Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks. Location: Miami, FL Department: Quality Assurance Reports To: Head of RA/QA Company: InspireMD (Class III PMA Medical Device) About Us: InspireMD is an innovative commercial stage startup focused on bringing cutting-edge Class III and Class II medical devices to the market. We are seeking a motivated and experienced Director of Quality Assurance to join our growing team. This is an exciting opportunity to contribute to the success of a fast-paced growing company and play a pivotal role in ensuring the highest standards of quality for life-saving devices. Job Summary: As Director of Quality Assurance, US, you will be responsible for overseeing the development of site-specific SOPs for our new US headquarters and assessing the current QMS for any gaps/improvements as we move towards gaining approval of our first PMA in the US. This includes ensuring compliance with FDA regulations (21 CFR 820), ISO 13485, and other applicable standards. You will collaborate closely with cross-functional teams to ensure that products are compliant with regulatory requirements, maintain robust quality systems, and meet both internal and external quality standards. This is a key leadership role in a startup environment with growth potential and significant impact. Key Responsibilities: Quality Management Systems (QMS): Lead the development, implementation, and maintenance of the QMS in compliance with FDA regulations, ISO 13485, and other relevant standards. Regulatory Compliance: Ensure compliance with FDA 21 CFR 820, ISO 13485, and other applicable regulations for importing, manufacturing, and distributing medical devices. CMO & Supplier Quality Management: Work with local and global manufacturers to ensure the quality and compliance of products being imported. Manage the establishment of new manufacturing locations, quality agreements, supplier qualification, audits, and product performance monitoring. Quality Control and Product Release: Oversee quality control processes for incoming products, including inspections, testing, and release of products into the US market. Document Control and Records: Ensure proper documentation and record-keeping for all quality activities, including CAPA, non-conformance reports, risk management, and design controls. Corrective and Preventive Actions (CAPA): Lead the investigation, documentation, and resolution of product quality issues, including non-conformances, complaints, and CAPA processes. Internal Audits and Inspections: Plan, coordinate, and lead internal audits to assess the effectiveness of the QMS. Support external audits and FDA inspections as needed. Continuous Improvement: Promote and lead continuous improvement initiatives within the QA team and across the organization. Develop and implement best practices, quality metrics, and performance indicators. Cross-functional Collaboration: Work closely with Regulatory Affairs, R&D, and Operations teams to ensure alignment on quality and regulatory requirements, timelines, and product specifications. Qualifications: Education: Bachelor's degree in Life Sciences, Engineering, or a related field (required). Master's degree or advanced certification in Quality or Regulatory Affairs (preferred). Experience: 12+ years of experience in Quality Assurance within the medical device industry, including experience with Class III PMA products, with a minimum of 5 years in a leadership role. Proven experience managing QMS, regulatory compliance, supplier quality, and CAPA processes. Hands-on experience with FDA regulations (21 CFR 820), ISO 13485, and related standards. Proven ability to lead in a fast-paced, growth-oriented startup environment. Experience with global suppliers and international product importation is a plus. Skills: Strong knowledge of quality systems, product life cycle management, and regulatory requirements for medical devices. Excellent organizational, analytical, and problem-solving skills. Ability to manage multiple projects and priorities in a fast-paced environment. Strong attention to detail, accuracy, and documentation practices. Excellent communication and interpersonal skills, with the ability to work cross-functionally and lead quality initiatives. #J-18808-Ljbffr

Created: 2025-01-13