Medical Device Quality Engineer
Location: Boston, MA
Travel: Akili currently has two office locations, Boston and San Francisco. In order to support the management and workforce on both coasts, this position requires up to 25% domestic travel.
Akili is looking for a Medical Device Quality Engineer who will have an important role on supporting implementation of FDA 21 CFR Part 820, IEC62304, ISO13485 and EU MDD requirements within a fast-growing Software Medical Device (SaMD) company.
Specific duties include:
- Support on creating Forms, Work Instructions, and Standard Operating Procedures to prepare for ISO13485 certification
- Support on daily QE activities for successful achievement of long-term company quality objectives
- Support software verification activities
- Investigate Customer Complaints
- Investigate Non-conformances
- Conduct CAPA investigations and track action items
- Create and review Change Orders.
- BS degree in Science or Engineering preferred
- Minimum of 3 years’ experience
- Proficiency with 21 CFR Part 820, IEC62304, ISO 13485 & CE Marking requirements
- Ability to work in an FDA-regulated industry
- Observe and comply with quality policies, procedures and work instructions
- Ability to handle multiple tasks simultaneously and ability to manage project timelines
Reasonable accommodations will be made to enable individuals with different abilities to perform the essential functions.
Akili is an equal opportunity employer that embraces diversity and inclusion.