Quality Manager, Manufacturing & ISO

Does building and leading the quality function for an R&D and production facility delivering cutting edge innovative devices excite you? Would you excel as a Quality Manager in a manufacturing & ISO 9001 environment where you will own the entire Quality Management System while driving a culture of continuous improvement across R&D, production, and customer support? Are you energized by the concept of taking a highly visible leadership role where you’ll have the opportunity to shape processes, influence product development, and make a measurable impact on product quality and customer satisfaction?

If you answered yes, yes, yes, please apply to our Quality Manager role today!

• reviewing and enhancing the existing quality process and practice
• implementing, tracking and monitoring quality metrics throughout the organization to ensure it is achieving its goal of 100% out-of-box quality
• ensuring company wide compliance with ISO 9001 and that all process controls are in place to achieve the highest level of product quality in design, manufacturing and service

• Product responsibility for serial instruments (function, specification, quality, costs)
• Project responsibility during product development projects and especially serial transition
• Technical responsibility for customer projects

• Ensuring every staff member receives the appropriate mentoring and development needed to be successful by conducting regularly scheduled meetings and providing enriching guidance and feedback
• Initiating and implementing quality improvement activities as appropriate (e.g., Kaizen, Lean, Six Sigma, etc.) to raise the performance of the company’s product lines
• Managing the Quality Management System, support corporate audit activity, and work jointly with corporate compliance group on risk management processes
• Serving as the primary quality control resource for problem identification, resolution, and continuous improvement
• Designing, implement and document procedures for process control, process improvement, testing and inspection
• Creating a company quality control program by educating and training employees to proactively identify, analyze, track, control, mitigate and report issues
• Establishing and implementing industry best practice quality metrics (process capability, control charts, measurement quality) for monitoring system effectiveness
• Performing root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements
• Assisting Incoming QA Inspectors and Assembly Technicians in problem solving as needed
• Establishing collection and analysis systems of statistical data to predict trends that will affect improvement of product quality
• Preparing product and process quality reports by collecting, analyzing, and summarizing information and trends
• Completing quality assurance operational requirements by scheduling and assigning employees and following up on work results
• Granting technical approvals such as special approvals and approval of technical changes to serial products
• Taking responsibility for all instrument-specific, quality-relevant, and technical specifications of the products
• Ensuring instrument safety and adapting products to new norms and standards (together with CE)
• Leading and supervising error analysis and systematic solutions in case of problems to maintain process and product quality
• Performing regular monitoring and analysis of production costs and driving improvement projects involving cross functional teams (together with, CS, PE and production)
• Participating in projects during development according to PEP
• Acting as link between development, production and Customer Support with regard to alignment, technical implementation and questions
• Ensuring training of Customer Support, Repair and Assembly, QA or in some cases, other functional areas
• Reporting to management on quality issues, trends and losses
• Maintaining strong relationships with leaders across the organization related to quality and compliance plan issues
• Providing guidance and technical expertise to departments and projects that concern quality
• Participating in internal and external quality audits
• Identifying and leading initiatives that lead to quality improvements and cost reductions
• Supporting concurrent engineering efforts by participating in design development projects representing quality assurance and the customer
• Overseeing quality-related activities and tasks to maintain excellence in product development and product transition (R&D) to design and to manufacturing
• The position essentially requires up to 10% overnight travel domestically and internationally
• All other duties as assigned

• Bachelor’s Degree in a technical discipline
• Professional experience in quality management and/or quality assurance; preferably in a highly standardized environment such as manufacturing, automotive, aerospace or medical devices
• Past experience managing a…