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Urgent : Customer Quality Engineer II

Company:
LanceSoft Inc.
Location:
Raynham, Massachusetts, United States
Posted:
April 10, 2019

Description:

Duties:

• Serves as a liaison between the quality assurance department and other departments for complaint investigations; Interfaces with key business partners including research and development, regulatory and compliance, operations, service and repair, medical affairs, medical safety, post market surveillance and international affiliates as required

• Utilizes statistical tools and appropriate investigative techniques to analyze complaint root cause and corrective actions

• Ensures complaint investigations are robust and well documented

• Files MDR (Medical Device Reporting) and MDV (Medical Device Vigilance) reports as necessary to health authorities

• Escalates events in a timely manner and per procedure; Ensures key department metrics (such as complaint closure and health authority reporting timeliness) are met

• Prepares responses to customer inquiries regarding complaint investigations and prepares trend reports for complaints.

• Summarizes the results of various data analysis into clear and concise presentations and reports for peers, cross-functional teams and management

• Supports such activities as post market surveillance, complaint reports and safety signal detection

• Supports process improvement activities and the CAPA process as necessary

• Supports any Internal and External Audits as necessary

• Knows and follows all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times

• All other duties as assigned

Requirements:

• Minimum of Bachelor’s Degree is required, preferably in an Engineering, Life Science, or related discipline. An advanced degree is a plus.

• Minimum of 2 years of direct or related experience in a regulatory environment is required.

• Excellent problem solving, critical thinking, and decision making skills is required. Ability to conduct root cause analysis is required.

• Ability to prioritize and multi task.

• Ability to collaborate with technical and non-technical personnel at all organizational levels.

• Ability to work in a cross-functional and matrix environment; strong verbal and written communication skills.

• Demonstrates ability to respond to the urgent needs of the team, with proven track record of meeting deadline.

• Knowledge of basic medical terminology.

• An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.

• Proficient in MS Office (Word, Excel, Outlook, PowerPoint, SharePoint).

• This position is located in Raynham, MA and may require up to 10% travel.