Junior Quality Assurance Engineer

Position Overview

  • Reports to Manager, Quality Assurance
  • Full Time position
  • Competitive salary, stock option package and strong benefits

Summary
The Jr. Quality Assurance Engineer’s role is to assist the QA team in maintaining a quality management system (QMS) compliant to FDA regulation (21 CFR Part 820 and Part 11) and ISO 13485 standards. This position will support all levels of quality assurance and quality control activities.

Key Tasks

  • Maintenance and administration of BrainScope’s physical and electronic QMS
  • Maintain product specific quality records such as DHF, DMR and DHR
  • Develop and maintain quality system procedures including design controls, change control, CAPA, Complaint, Non-conformance
  • Maintain qualification, calibration and preventive maintenance documentation for test equipment
  • Develop, conduct and monitor employee training
  • Support internal and external audits and inspections
  • Support verification and validation activities

Job Requirements

  • Bachelor’s degree in Engineering or equivalent
  • 2+ years’ experience with FDA and ISO regulated product development and ISO quality systems
  • Experience or working knowledge of ISO 13485, 21 CFR Part 820 and 21 CFR Part 11

Skills and Abilities        

  • Proficient with the use of MS Office Products (Word, Excel, PowerPoint SharePoint) and Adobe Acrobat
  • High attention to detail and meticulous record-keeping
  • Ability to work both independently and as part of a highly integrated team
  • Comfortable working in a fast paced environment
 
 

Qualified applicants are encouraged to send their resume and a cover letter including availability to recruiting@brainscope.com. 


 

The Office of Federal Contract Compliance Programs (OFCCP) has released a Voluntary Self-Identification Form CC-305. All federal contractors are required to use this form in inviting all applicants and employees to provide information regarding their disability status. Completing this form is voluntary and any answer you give will be kept private and will not be used against you in any way. If you choose to complete the form, please attach it with your job application. The form can be found at http://www.dol.gov/ofccp/regs/compliance/sec503/Voluntary_Self-Identification_of_Disability_CC-305_SD_Edit1.24.14.pdf