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Senior Quality Engineer (Complaints)

Expired Job

Senseonics Germantown , MD 20874

Posted 4 months ago

08/20/2018

About the Position

The primary responsibility of the Senior Quality Engineer (Complaints) is to support the global reporting obligations and the management of communication between manufacturer, distributors and competent authorities for all medical device complaint related activities, including assistance of and/or submission of medical device event reports in accordance with applicable local laws and regulations.

Job Responsibilities

  • Provide understanding, leading analysis and management of information regarding medical device complaint events and/or adverse events, follow-up, case processing and assessment for post-marketing activities including:

  • Receives, documents and evaluates complaint information

  • Evaluates and engages appropriate management for critical and/or unusual events. Liaises with internal functions (Quality, Regulatory, Medical Affairs, Customer Service, Manufacturing and R&D) to gather critical input into medical device event reports

  • Reviews complaint investigation reports and provides comments in accordance with procedures

  • Ensures complaint files are closed in a timely manner

  • Performs and/or documents regulatory decisions on complaints in accordance with applicable local laws regulations

  • Communicates with local and international competent authorities, including generation and/or submission of medical device event reports as required by applicable local laws and regulations

  • Coordinates and prepares responses to competent authority inquiries associated with medical device report submission (Serious Injury and/or Device Malfunction)

  • Participate in preparation for Notified Body audits and or Competent Authority inspections

  • When required, support root cause investigations and participates in CAPA (Corrective and Preventative Action) activities

  • Generate complaint handling trending reports for management reviews and regulatory submissions as required

Job Requirements

  • Working knowledge of 21 CFR 820, 21 CFR 803, ISO-13485, ISO-14971, MEDDEV Vigilance Guidance, European Medical Device Regulation

  • Bachelor's Degree in scientific or engineering discipline required

  • Minimum of 3 years related work experience is required

  • Position requires strong written, oral and listening communication skills to interact with various departments and other professionals with varying backgrounds

  • Must be able to generate and organize clear, concise responses when communicating with various levels of management

  • Great organizational skills to be able to manage challenging deadlines

  • Able to perform job function with minor supervision and make independent decisions, where appropriate

  • Proficient in the use of personal computers, including database management, trending and word processing

  • Recognizes problems and suggests applicable solutions

Senseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits. For consideration, please submit your resume electronically to HR@senseonics.com.


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Senior Quality Engineer (Complaints)

Expired Job

Senseonics