Quality Engineer (Compliance investigator) - Intellectt INC

Role: Compliance investigator
Location: Burlington, MA
Duration: 06+ Months

Main Purpose of Role:
Perform failure analysis on explanted biomedical implant product. Provide technical expertise to the Product Analysis Laboratory. Analys failures, develops, and implements investigative protocols to identify root causes, performs circuit analysis, performs device and component level failure analysis.

Main Responsibilities:
Perform failure analysis on explanted long-term biomedical implant product.
Work requires the application of theoretical principals, evaluation, ingenuity, and creative/analytical techniques to identify
route cause failure mechanisms.
Must be able to meet deadlines on multiple assignments and be able to operate in a diverse cross-functional team environment.
Proactive in finding quality improvements related to Failure Analysis
May serve as lead and assign work to less experienced personnel and serves as a mentor when assisting less experienced lab staff in solving more complex problems.
Works cross functionally and collaboratively with Product Development, Engineering, Manufacturing, and Product Surveillance.
Aides in definition of test equipment as required to accomplish quality responsibilities.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS),Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, vendors.

Education & Qualifications:
Bachelor's Degree in Engineering is Required
Electrical or Biomedical Engineering or Regulatory Affairs is preferred
Engineering work experience is preferred
Knowledge of global regulations for medical device reporting and medical terminology is a positive
Strong written and oral communication skills are required
Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously
Multitasks, prioritizes, and meets deadlines in a timely manner
Strong organizational and follow-up skills, as well as attention to detail