Quality Engineer II

US-VA-Manassas
3 weeks ago(11/29/2017 2:35 PM)
Job ID
2017-28445
Category
Quality Assurance
Position Type
Contract (Full-Time)
# of Openings
1

Overview

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. 

Responsibilities

  • 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. 

 

Qualifications

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 

 

Required: 
• 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 

Desired: 
• 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

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Need help finding the right job?

We can recommend jobs specifically for you! Click here to get started.