Location
Danvers, MA | United States
Job description
Role : Quality Engineer
Location : Danvers, MA
Duration : Long Term
The Quality Engineer I (Contractor) in the Post Market Engineering group plays an integral role in Clients Quality Department and specifically with post-market investigations of FDA-approved medical devices. This position is not a hands-on engineering role; instead, it specializes in documentation and review of complaint investigation reports in collaboration with the electrical engineering team. This role involves analyzing failure investigation evidence, performing risk assessment, and documentation of the investigation report in the complaint management system.
Principle Duties and Responsibilities:
- Assist complaint investigations by reviewing clinical notes, interpreting electrical engineering laboratory notebooks, and documenting the root cause investigation with emphasis on risk assessment
- Responsible for identifying high-risk failures to improve product quality and reliability
- Develop work instructions for failure analysis to improve investigation processes and testing methods
- Apply statistical tools to analyze data and drive problem resolution
- Support corrective and preventive actions in a timely manner to prevent the recurrence of problems
- Support engineering projects that introduce change to the design or process
Job Qualifications: - BS in Engineering or directly related scientific discipline required
- 1+ years of related work experience
- Experience interpreting data associated with electronic medical devices
- Ability to communicate ideas and information clearly, effectively, and frequently (oral and written)
- Determination to overcome obstacles and the initiative to execute tasks in a timely manner without direct supervision
- A passion for medical devices and making a significant positive impact on the lives of our patients
- Must be proficient in Microsoft Office Suite. Working knowledge of SAP desired
Preferred Qualifications - Medical device quality experience preferred
- Knowledge of medical device manufacturing and servicing techniques
- Cross-functional experience with clinical teams and complaint specialists
Job tags
Salary
