Join Team Vave
We are on a mission to change the paradigm of healthcare, starting with ultrasound.
Vave Health is a healthcare technology startup based in the Bay Area. Our next-generation wireless ultrasound solution enables faster diagnosis and treatment at the point of care resulting in better patient outcomes. We believe that by working passionately in concert with clinicians and other creators, we will bring the most efficient and effective products to the medical field. Vave is accelerating access to imaging by designing the first wireless ultrasound-as-a-service platform. The low-cost subscription includes a portable ultrasound device, intuitive software, and Vave Health’s customizable educational platform. Our mission is to increase access to innovative imaging, improving the quality of care for those who need it most.
At Vave Health, we are committed to equal employment opportunities. Vave company offers a drug-free work environment to all qualified applicants without regard to race, religion, color, sex, age, national origin, sexual orientation, disability, marital status, veteran status, or any other category protected by applicable law. Equal employment opportunity includes hiring, training, promotion, transfer, demotions, and termination.
Head of Quality & Regulatory
Develop, implement, and lead the Company’s quality, regulatory, and compliance efforts aligned with the overall mission and goals of the organization and integrated with clinical, operations, and marketing efforts. Serve as the company’s Management Representative, and lead contact (Qualified Person) for regulatory agencies and Notified Bodies.
As Head of Quality and Regulatory, this individual is responsible for supporting exceptional product quality and reliability ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with regulations, standards, and industry practices. Working closely with cross-functional teams this individual will act as a subject matter expert for the electronic quality management system and the requirements and risk management system. The individual will be responsible for supporting other areas of the Quality Management System such as CAPA, Complaints.
SPECIFIC DUTIES AND RESPONSIBILITIES
- Plan, design, and implement a comprehensive quality system that complies with relevant FDA GMP Design Control and ISO 13485 regulations appropriate for the Company’s products
- Lead the implementation of the QMS and work co-operatively with R&D, marketing, operations, and others within the company to drive improvements in customer satisfaction, productivity, regulatory compliance, and company efficiency
- Plan, execute, and manage quality assurance systems and activities including quality engineering, product release, CAPA/non-conforming system, complaint investigation, document control, and training systems, ensuring compliance with regulatory and company requirements
- Serve as the site host during 3rd Party audits, i.e. Notified Body, FDA, and other regulatory agency compliance inspections and coordinate responses
- Maintain strong relationships with regulatory agencies, competent authorities, and standards organizations that impact the Company
- Manage and maintain the internal and supplier audit system, the corrective/preventive action system, the control nonconforming material system, complaint system, document control system, and others as required
- Work closely with other departments to ensure projects conform to all regulatory and quality requirements
- Assure the plant is compliant with cGMP regulations and is maintained in an inspection-ready status
- Implement proactive quality programs to prevent compliance problems, reduce losses, and assure timely release of products
- Assist in preparation of reports, summaries, and other data to support product and establishment regulatory submissions
- Coordinate and facilitate periodic Management Review to inform management of compliance risks, improvements, and current status of the Quality System
- Provide quality training to site staff and new hires in the use of the quality system and associated regulations
- Ensuring the promotion and awareness of regulatory and customer requirements throughout the organization
- Ensuring the company operates in compliance with state, federal, and international laws and regulations governing the manufacture and distribution of medical devices
- Reviewing technical problems and procedures and recommending solutions
- Ensuring representation of Quality Assurance at design and development meetings
- Participates with the CEO and other executives in formulating current and long-range strategies, objectives, and global policies
- Provide coaching and guidance on job performance and career development to direct reports; builds and directs talent-building and development objectives for the organization; builds a culture of continuous improvement
- Bachelor’s degree preferred
- Degree in life sciences or engineering preferred
- A minimum of 15 years experience in quality operations in the Medical Device industry and a minimum of 10 years of supervisory experience
KNOWLEDGE AND TRAINING
- Knowledge and competency in the application of FDA, ISO 13485, ISO 14971, MDD, MDR, and other regulatory requirements, especially in Quality Systems and Design Control as applied to projects from design inception to manufacturing release, is required
- Solid understanding and relevant experience in software/hardware/mechanical design verification and validation methods
- Ability to balance the needs of a fast-paced start-up environment with the needs for good documentation and quality control
- Experience in implementing and managing documentation/configuration control systems
- Experience with FDA/ISO design control audits
- Experience with the following techniques: Hazard Analysis, Risk Analysis, FMEA
- Quality systems implementation and maintenance experience required.
- Demonstrated abilities in building and leading cross-functional/cross-site teams, time and budget management influencing and working well with others in a proactive and constructive manner, and communicating clearly, in both verbal and written forms, within all levels of the organization are required.
- Experience preparing and executing training programs, internal and vendor quality auditing, and interactions with regulatory agencies and customers in inspections and audits.
- Experience with all phases of the product development lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization
- Experience in cGMP and other regulatory compliance requirements
- Hands-on experience with FDA Federal and State Audits
- Respected leadership skills, with steadfast resolve and personal integrity
- A solid grasp of data analysis and performance metrics
- Ability to diagnose problems quickly and have foresight into potential issues
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
- Must be comfortable in a fast-paced small company environment with changing priorities
- The ability to think strategically and execute tactically – so that plans are well-thought-out and action is taken effectively
- A willingness to roll up your sleeves and do what is needed in a start-up environment
- Excellent leadership skills including a demonstrated ability to work with various functional areas, self-awareness of strengths and weaknesses, and an understanding of when to pull in appropriate expertise when needed
- Demonstrate a track record and leadership in building organizational and staff capacity, developing a strong workforce and culture of accountability, and developing processes that ensure that the company runs smoothly and efficiently