Medical Device Quality Engineer

Location
02110
Posted
Feb 21, 2018
Required Education
Bachelors Degree
Position Type
Full time

 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.

Job Description:

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. 

Qualifications:

  • 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

Accommodations:

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.