Ambu Work Values

Daily Duties at Ambu:

I was over all Quality activities: *Provide leadership to the following staff: Quality Assurance Manager, Quality Engineers (3), Program Manager (1), Quality Analyst (3), Team Leads (3), Calibration Technician, Documentation Control Specialist and Quality Assurance Technicians (24). *Forecast, plan, and direct resources to achieve department and company objectives and participate in long-range business planning and budget preparation *Report to corporate on the Quality Management System at Noblesville Indiana facility *Develop Corporate Quality Control Plan to support Noblesville Quality Activities *Implemented and oversight of a Corporate Quality Management System *Analyze, evaluate, and present information concerning business and quality issues relative to the design, development, and manufacture or distribution of products. *Management Representative with regulatory agencies (FDA, Notified Body, etc.) relative to medical device design, manufacture, re-packing, and distribution. *Review technical reports and summary documents for quality and adherence to regulatory guidelines, strategies, and commitments. *Manage the CAPA (corrective action & preventative action), NCR (Nonconformities process) and Complaint process to drive timely closure of actions. *Manage the Quality Auditing System, including auditors training. *Review the documented Quality System for continued adherence to, 510(k) submissions & technical files *Facilitate Management Review Meetings at Noblesville and with Corporate *Work with other top management personnel in formulating and establishing company policies, operating procedures, and goals. *Review technical problems and procedures of Quality Assurance and recommend solutions to problems or changes in procedures. *Review technical publications, articles, and abstracts to stay abreast of technical and regulatory developments in industry. *Plan, promote, and organize training activities related to Quality Systems requirements. *Evaluate performance and approve compensation changes on all subordinates.and also was the Management Representative during ISO recertification and FDA Inspection.

What they like about Ambu:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory

Skills

These are some of the questions we asked our climbers about their experiences with Ambu: