Customer Quality Assurance Engineer
ZOLL Medical Corporation - Chelmsford, MA

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Title: Customer Quality Assurance Engineer

Job Summary:

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.

Essential Functions:

-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.

Required Skills Skilled Requirements:

-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.

Required Experience Education:

-Four year engineering degree (BSEE, BSME desirable)

-Training in Statistical Analysis

-Training in analytical quality problem solving tools

-Certified Quality Engineer- CQE preferred

Requirements:

-Current Passport

-Valid Driver's License

-Credit Card in good standing for expenses related to traveling.

Zoll Medical Corporation - 16 months ago - save job - block
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