The Quality Director is responsible for ensuring that our products and services are fit for purpose through the development and implementation of effective Quality Management System (QMS) strategies and programs within NanoString, including compliance with ISO 13485 and FDA GMPs where applicable.
The scope of responsibility spans Suppliers to Inputs to Process to Output to Customers. These responsibilities are fulfilled by addressing the availability and capability of materials, people, equipment/processes, systems and facilities using world-class QMS approaches and techniques.
Role will report to the Senior Vice President, Operations.
Provide direction, supervision, and guidance to ensure alignment with quality policy, strategic objectives and organization goals that drive to Platform Reliability plans and strategy for Life Cycle Management.
Collaborate with senior leadership for planning, execution, and management of process improvements, projects, and other initiatives.
Develop and implement quality plans, procedures and company policies
Ensure performance and quality products conform to established company and regulatory standards
Review, analyze and report on quality discrepancies and data related to production
Lead integrated senior management teams to determine strategy and tactical deployment, improve performance, lower costs, and generate innovative solutions
Investigate problems and develop disposition and corrective actions for recurring discrepancies
Interface with stakeholders and contract manufacturing partners to ensure requirements are met
Recommends corrective actions, dispositions, process optimization and modifications
Establish strategy, direction and application of continuous improvement through Systems and Tools, Teaching (Training Curriculums and Mentorship), and Deployment
Establish and maintain best practices in areas of business processes, KPIs, and analytics
Required Skills and Education
BS in Science and/or Engineering required, prefer MS and/or MBA
Minimum 10 years of relevant work experience in Operations, Engineering, and Quality, preferably with 5 years' experience as a QA Director
Must possess a strategic perspective, leading vision and values, global acumen, and leadership disposition
Must be skilled in strategic thinking, managing through systems, innovation management, and negotiation
Strong analytical and problem-solving skills
Organizational skills - can marshal resources to get things done, orchestrate multiple activities at once to accomplish a goal, use resources effectively and efficiently, and arrange information in a useful manner.
A passion for excellence.
Preferred Skills and Education
Proficient in leveraging quality science tools, processes and people
Certified Quality Auditor
Approachable hands-on style with the ability to engage with people at all levels of management. Customer experience and Quality Excellence
Demonstrated track record of recruiting, retaining and promoting talent (executive and managers) and creating high performing teams
Must be able to demonstrate accomplishments in setting strategic direction, prioritizing tasks, and overcoming obstacles
Possess a deep understanding of the talent and skill sets required to sustain innovation and long-term growth within a technical organizational
Must possess strong verbal and communication skills, and a well-developed ability to constructively work across functional areas and levels to achieve results
NanoString is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. NanoString does not accept unsolicited agency resumes and will not pay fees to any third-party agency or company that it does not have a signed agreement with.