Director, Quality Assurance

About Akura Medical

Akura Medical, part of the Shifamed portfolio, is building a distinct platform for treating venous thromboembolism (VTE), a condition that impacts as many as 900,000 people in the United States each year. The company has obtained US IDE approval for its QUADRA-PE study, which is assessing the Katana™ Thrombectomy System for patients with acute pulmonary embolism. Alongside this, Akura Medical is creating NavIQ™, a software solution that converts CT angiograms into 3D pulmonary vascular models to improve visualization, procedural planning, and clot evaluation with the goal of improving safety, effectiveness, and ease of use. The company has also completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, to support a joint venture and a new research, development, and manufacturing center in Doha, Qatar.

About Shifamed

Founded in 2009 by entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on creating novel products that address unmet clinical needs in the fast-moving fields of cardiology and ophthalmology.

Role Overview

The Director, Quality Assurance will own the creation, rollout, and ongoing management of quality systems and practices. The role is responsible for ensuring that product development, manufacturing, testing, and release activities align with applicable federal and state regulations, international standards, and the company’s Quality Policy.

Core Responsibilities

• Maintain alignment with applicable quality system regulations and standards, including FDA QSR, ISO 13485, MDR, GMP, and design controls.
• Work closely with R&D and Operations to define and sustain quality expectations across development, transfer, manufacturing, and post-market activities.
• Own and maintain Design History Files (DHF), Risk Management Files, and related quality records for products and processes.
• Plan and execute quality engineering work such as design verification and validation, process validation, equipment qualification, test method validation, and first article inspection.
• Oversee manufacturing quality operations including inspection workflows, nonconformance reviews, CAPA, root cause analysis, and continuous improvement efforts.
• Build, update, and control manufacturing and quality records such as procedures, inspection instructions, Lot History Records, and Bills of Materials.
• Lead supplier quality activities, including supplier qualification, audits, source inspections, supplier controls, and ongoing performance tracking.
• Prepare for and support internal, customer, supplier, and regulatory audits and inspections.
• Coordinate quality system training and strengthen organization-wide awareness and adherence to quality requirements.
• Support complaint handling, MDR/vigilance reporting, field actions, and investigations into product or process issues.
• Represent Quality on cross-functional project teams and serve as site Management Representative and/or Quality signature authority when needed.
• Manage and develop Quality Assurance team members to ensure strong execution of quality and regulatory responsibilities.
• Perform additional duties as assigned.

Experience and Qualifications

• Master’s or bachelor’s degree in engineering, a scientific field, or an equivalent combination of education and relevant experience.
• At least 15 years of experience in quality or technical management within the medical device industry or a related area.
• Prior direct people management experience is required.
• Experience leading a company into regulatory compliance and approval is preferred.
• Strong working knowledge of FDA regulations and the ability to interpret FDA regulations, guidance, and policy statements.
• Knowledge of international regulations, standards, and guidance, including MDR, ISO 13485, ISO 14971, IEC 60601 and related collateral standards, IEC 62304, IEC 62366, and FDA cybersecurity guidance.
• Ability to train team members on processes and procedures.
• Excellent written and verbal communication skills.
• Ability to work effectively across functions to achieve business outcomes.
• Willingness to travel as needed.

Additional Information

Salary ranges are determined based on role, level, and location. Final compensation depends on relevant job knowledge, location, skills, experience, education, and training or certifications.

Notice to Candidates

Shifamed and its portfolio companies do not interview candidates or make offers through mobile web chat applications. Any such activity should be reported to [email protected].