Quality Engineer

Overall Responsibilities: We have an exciting opportunity for a Quality Assurance Engineer to join our highly innovative and collaborative team.  This role will be responsible for growing and strengthen the quality department and Quality Management System (QMS).  This position will assist with expanding the system already in place and help to foster a “quality culture” on a global scale. Additionally this position will be responsible for improving the customer complaint process to help investigate quality issues and work to ensure they don’t happen in the future, overall improving the customer experience with Genus.

 

Specific accountabilities:            

  • Build upon and comply with company quality assurance standards.
  • Work with other teams, locally and globally, to improve knowledge and adherence to systems, policies, and procedures.
  • Document quality assurance activities with internal reporting and audits.
  • Expand the recording and tracking systems for RCAs and CAPAs and then maintain the process.
  • Update and improve the customer complaint process to ensure capture of investigation as well as all proper documentation.
  • Assist with development of IQC standards for all necessary reagents and consumables.
  • Assists the Quality Assurance Analyst with document control including document creation and revision.
  • Supporting regulatory submission questions and on-site audits.
  • Mentoring peers and lower level Quality Analysts in the application of Risk Management requirements and industry best practices.
  • Comply with established quality, safety, and environmental procedures and policies

 

Qualifications and experience:

  • Bachelor’s Degree
  • Professional certification, like Lean/Six Sigma preferred
  • Knowledge and experience with a Quality Management System
  • Regulatory experience is desired
  • Advanced computer competence, including database management
  • Familiarity with Microsoft teams and SharePoint strongly preferred
  • Knowledge of quality assurance terminology, methods, and tools
  • Excellent interpersonal and communication skills
  • Analytical, problem-solving, organized, and detail oriented
  • Basic biology or mechanical background a plus

 

Capabilities and behaviors:

  • Lives and displays the Genus ABS Values and behaviors at all times in their day to day ways of working.
  • Maintain professional verbal and written communications with co-workers, internal and external customers, and vendors at all times.
  • Be flexible with respect to job responsibilities and consistently strive to be an effective team member.
  • Strive to advance your skills and display a willingness to accept future development.
  • Actively participate in Company training opportunities to further develop skills applicable to the department.

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