The Director of Quality Assurance will be responsible for the Worldwide Vispero Quality Assurance. This position reports into the Vice President of Worldwide Operations.
The Director will be a member of the Operations Leadership Team. As such they will work with the Leadership Team to set business strategies, allocate resources, and set business priorities. They will ensure Quality Management System and product quality issues are appropriately identified and managed across the business.
Ensure the Vispero Quality Assurance organization has the capabilities to execute on the business strategies and maintain a substantially compliant Quality Management System.
Consistently exhibits behavior and communication skills that demonstrate Vispero’s commitment to superior customer service. Implementing programs that utilize Voice of the Customer to drive a proactive approach through Quality and Technical Support groups.
Ensures that all quality and customer experience goals are met or exceeded and implements plans to close any identified gaps from expectations and to demonstrate continuous improvement.
Provide continuous improvement and lean culture development for the Quality, Tech Support and Compliance groups within Vispero.
Ensure Quality Management System and all Regulatory compliance elements are effectively implemented in all phases of the operations and engineering process.
Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance.
Set SLA and procedures for the quality department to resolve product issues, ensuring staff adhere to expected practices and are customer obsessed with a goal of customer satisfaction. Drive and measure to ensure service level expectations are met by staff.
Develop and nurture highly effective collaborative relationships across Engineering, Product, Operations and Sales teams to deliver a world class support experience.
Communicates quality information throughout the organization by creating a cross functional team to drive a standardized quality reporting process.
Evaluates tools used in the process and optimizes use of them, determines when changes are needed and leads the change.
Ability to put together executive level reporting around quality, compliance and technical support.
Responsible for the company’s overall compliance risk and regulatory requirements around ISO 13485 and Medical Device Regulations. Ensuring products manufactured at Vispero meet company quality standards and government regulations.
Additional Key Responsibilities:
Responsible for planning, developing, and directing quality assurance policies, programs, and initiatives.
Responsible for the technical support team for hardware and software product lines.
Develop a robust quality management system in line with ISO 13485 processes.
Develop departmental key performance indicators and analyze for opportunities to optimize department performance and improve customer experience
Quality and/or Risk Management experience including primary responsibility for performance improvement activities, regulatory compliance, conflict resolution, leadership, and risk management activities.
Developing and monitoring Quality programs, policies, and procedures to ensure compliance with OSHA, Safety, and other company standards.
Travel required up to 35% of time with extended stays in the U.S. and Europe.
BA or BS in technical or related field
Experience with Medical Device Regulation and ISO 13485 Certification and Compliance
Relevant experience in Quality Assurance, Engineering, Continuous improvement
Typically requires 10+ years of managerial experience.
Knowledge of safety requirements and legal standards
Experience with MS Word, Excel, Project Management and Analytics software
If you have a passion for excellence and want to work with an outstanding team of experts, working in an exciting, challenging, fast paced environment for the world’s leading assistive technology company, please apply here.
If you have a passion for excellence and want to work with an outstanding team of experts, working in an exciting, challenging, fast paced environment for the world’s leading assistive technology company, please send your resume to email@example.com.
Vispero actively seeks to develop greater levels of diversity in our workforce and in our pipeline of future employees. We are committed to attract and retain candidates who have a passion for their work and encourage all individuals to apply. Vispero is an Equal Opportunity Employer.