Title: Customer Quality Assurance Engineer
Support the field side of the organization (post market surveillance) in a cross functional environment, interacting with a risk based complaints, supporting CAPA and addressing customer needs.
-Ability to lead product quality investigation to a successful conclusion.
-Assess CAPA requests for viability.
-Provide assistance in reportable investigations involving customer returned product and no sample returns.
-Identify corrective actions. Interface with other departments as necessary to implement correct actions.
-Collect, analyze, trend and disseminate quality data throughout the organization.
-Up to 40% travel related to customer investigations and escalations. May include international travel.
-Participate in Engineering Change Order review process.
-Ensure daily procedures and work instructions are in accordance with established policies, standard operating procedures, ISO13485 and FDA's QSR.
-Practice dynamic communication within all facets of ZOLL to ensure smooth workflor and timely completion of tasks.
-Assume additional responsibilities as necessary at the discretion of Manager, Director or Vice President.
-Ability to manipulate data in EXCEL and ACCESS software
-Proficient with MS Office
-Excellent communication skills
-Self starter, decision maker
-Minimum 5 years related experience in a regulated environment, preferably medical device.
-Minimum 5 years experience managing customer related projects including face to face communication, strategy and setting expectation.
-Four year engineering degree (BSEE, BSME desirable)
-Training in Statistical Analysis
-Training in analytical quality problem solving tools
-Certified Quality Engineer- CQE preferred
-Valid Driver's License
-Credit Card in good standing for expenses related to traveling.
Zoll Medical Corporation - 16 months ago