Sr. Manager, Quality Engineering

Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing NavIQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar.

About Shifamed Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description:

This position is responsible for the development, implementation, and management of quality systems and practices. This position will oversee and ensure that the development, manufacture, testing and release of products are performed according to the applicable federal and state regulations, international standards, and the Company’s Quality Policy.

Responsibilities, Skills & Hands-On Experience:

• Ensure compliance with applicable Quality System Regulations and standards, including FDA QSR, ISO 13485, MDR, GMP, and Design Controls.
• Partner with R&D and Operations to establish and maintain quality requirements throughout product development, transfer, manufacturing, and post-market activities.
• Lead and maintain Design History Files (DHF), Risk Management Files, and associated quality documentation for products and processes.
• Develop and implement quality engineering activities including design verification/validation, process validation, equipment qualification, test method validation, and first article inspections.
• Support manufacturing quality activities including inspection processes, nonconformance investigations, CAPA, root cause analysis, and continuous improvement initiatives.
• Develop, maintain, and oversee manufacturing and quality documentation including procedures, inspection instructions, Lot History Records, and Bills of Materials.
• Manage supplier quality activities including supplier qualification, audits, source inspections, supplier controls, and ongoing quality performance monitoring.
• Prepare for, host, and support internal, customer, supplier, and regulatory audits and inspections.
• Coordinate quality system training and promote company-wide quality system awareness and compliance.
• Support complaint handling, MDR/vigilance reporting, field actions, and investigation of product or process failures.
• Serve as Quality representative on cross-functional project teams and act as site Management Representative and/or Quality signature authority as required.
• Lead and manage Quality Assurance resources to ensure effective execution of quality system and regulatory compliance activities.
• Other duties as assigned.

Education & Work Experience:

• Bachelors or Masters in Engineering or scientific discipline, or equivalent relevant work experience
• 12+ years of Quality or Technical Management experience in the medical device industry or a related field.
• Previous direct people management experience.
• Previous experience bringing a company into regulatory compliance and approval, preferred.
• Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines, and policy statements.
• Solid knowledge of international regulations, standards, and guidelines (i.e. MDR, ISO 13485, ISO 14971, IEC 60601 and collateral standards, IEC 62304, IEC 62366, FDA guidance documents for cybersecurity).
• Ability to train others in processes and procedures.
• Excellent communications skills (both written and verbal) required.
• Ability to work effectively across functional lines to reach effective outcomes for the business.
• Ability to travel as required.

Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications.

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to [email protected].