Quality Assurance Specialist

NuGEN Technologies is looking for a talented Quality Assurance Specialist to join our team. The successful candidate will support efforts to ensure NuGEN’s quality system is effective and compliant with ISO 13485. The individual will work closely with a wide variety of individuals and teams to support compliance activities and identify opportunities for continuous improvement.

Position reports to Director of Quality Assurance and needs to be filled immediately.

Please send inquiries and updated resume to careers@nugen.com.


19 May 2017

Role and Responsibilities

  • Supports compliance, maintenance, and continuous improvement of ISO 13485 certification
  • Actively participates in external audits in support of Management Representative
  • Conducts effective root cause analysis investigations and impact assessments for product and process deviations, assesses immediate containment actions
  • Reviews and approves change orders
  • Reviews and approves QC documentation for product release
  • Manages document control system and companywide training program
  • Manages customer complaint process
  • Conducts internal audits and inspections
  • Reviews and analyzes data and documentation
  • Manages projects related to yearly Quality Objectives
  • Follows-up with key stakeholders to ensure timely completion of action items related to the Quality Management System

Experience

  • Bachelor's degree or equivalent experience required
  • Minimum of 2 years experience in a quality assurance role in a Life Sciences company required; ideally in a ISO 13485 environment
  • Familiarity with commonly used Root Cause Analysis tools
  • Excellent verbal and written skills  
  • Outstanding attention to detail required
  • Strong organizational and interpersonal skills required
  • Excellent MS Office skills required
  • Flexibility and adaptability required