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Responsible for conducting investigations complaints, filing MDR and MDV reports to health authorities, and communicating performance and safety issues. In addition, this position is responsible for summarizing the results of data analysis into clear and concise presentations and reports for peers, cross-functional teams and management. This position will support business partner processes in post market surveillance, regulatory, operations and new product development. The Customer Quality Engineer works collaboratively with Quality, Manufacturing, Product Development and other functional experts. We are counting on you to be knowledgeable regarding regulations and standards affecting Medical Devices (e.g. ISO9001/13485/14971/14001, FDA Regulations (21CFR (803, 806, 820, part 11, etc.), CMDR, and Medical Devices Directive (93/42/eec, 98/79/EC)).
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
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.
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