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:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

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: