Quality Engineer II

3 weeks ago(11/29/2017 2:35 PM)
Job ID
Quality Assurance
Position Type
Contract (Full-Time)
# of Openings


Quality Engineer – Method Development/Validation Specialist 
Shift: M-F 8-5 
Role Purpose: 

Develops, modifies, applies and maintains quality evaluation systems. Devises and implements methods and procedures for producing, inspecting, testing, and evaluating products. Areas of specialization include: method design, validation, statistics, product evaluation. 


  • Participate in project team to quickly and effectively implement improvement initiative consistent with FDA requirements for medical device products. 
  • Provide technical support and guidance to other Mediatech staff and/or project team members in Quality Systems improvement efforts. 
  • Apply quality engineering practices and guidance to support project team using Six Sigma tools, FMEA, CE Diagram, CE Matrix, DOE, MSA, Validation Protocol development, review, approval and Control Plans. 
  • Develop innovative quality assessment strategies. 
  • Develop/Revise Quality Plans including: incoming, in-process and final inspection, and provide training to those affected by the plans. 
  • Perform technical reviews and interprets data for accuracy. 
  • Write Technical Reports and Protocols, as needed, and write, revise, and review SOPs. 
  • Frequently interacts with colleagues, team members, supervisors, and other teams/departments. 
  • Complies with the change management program to assure there is a proper technical review of requested changes and that there is a risk assessment of requested changes. 
  • Some travel may be required as part of the job responsibilities. 



Minimum of a 4-year degree in relevant fields of study such as microbiology, chemistry, biology, or engineering 3 - 5 years of relevant work experience 

Ideal candidates- Familiar with method validation tools- ie. MSAs and Guage R&R 
Should have experience with USP Testing Methods 
-Cell Culture testing 


• Minimum of a 4-year degree in relevant fields of study such as microbiology, chemistry, biology, or engineering, 3 - 5 years of relevant work experience 
• Minimum 1 year cell culture testing experience 
• Minimum 1 year new method development experience 
• Experience applying DoE (design of experiment) 
• Capable of applying relevant statistical techniques to quality evaluation methods 
• Demonstrated technical writing skills 

• Advanced degree 
• Method validation authorship and execution (preferably in cell culture applications) 
• Familiarity with cGMP, ISO 9001, ISO 13485, QSR 21 CFR 820, 210, 211 is highly desirable 
• Capable of Certified Quality Engineer recognition by ASQ 
• Six-Sigma / Lean Certification 
• Proficiency in Minitab, MS Project


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