Quality Manager, Manufacturing & ISO 9001

Anton Paar QuantaTec IncBoynton Beach, FL
Onsite

About The Position

The Quality Manager will build and lead the quality function for cutting-edge innovative devices in a manufacturing & ISO 9001 environment. This role involves owning the entire Quality Management System and driving a culture of continuous improvement across R&D, production, and customer support. It is a highly visible leadership position with opportunities to shape processes, influence product development, and make a measurable impact on product quality and customer satisfaction. The Quality Manager is responsible for championing a world-class quality system and developing a quality culture within the organization.

Requirements

  • 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 certified QMS (i.e., ISO 9001:2015)
  • A strong understanding of, and experience with, quality principles, tools and respective methodologies (i.e., Root Cause Analysis, Lean / Lean Six Sigma, Continuous Improvement, etc.), and be a change agent
  • Must have strong business acumen and excellent written and verbal communication skills
  • Ability to obtain a Passport for international travel

Nice To Haves

  • SAP experience
  • Experience with scientific instrumentation

Responsibilities

  • 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
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