The Director of Quality will be responsible for the Worldwide Vispero Quality Assurance, Compliance and Technical Support functions. This position reports into the Vice President of Worldwide Operations.
The Director will be a member of the Operations Leadership Team (LT). As such they will work with the LT to set business strategies, allocate resources, and set business priorities. They will ensure QMS and product quality issues are appropriately identified and managed across the business.
QA Director Job Responsibilities:
Ensure the Vispero QA 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 policies and procedures for the technical support department, 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.
Education and Experience Requirements:
BA or BS in technical or related field
Experience with Medical Device Regulation and ISO 13485 Certification and Compliance
10 to 15 years of relevant experience in Quality Assurance, Engineering, Tech Support, Compliance
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 send your resume to firstname.lastname@example.org.