Quality Engineer - Cell Culture Testing - Manassas, VA
One of the world’s leaders in materials science, our client has an opening for a Quality Engineer to work on a team at our client site in Manassas, VA. Imagine everything that you could learn to advance your career while working at a company with a 166–year track record of creating life-changing inventions. This position seeks talented candidates who will put the customer at the center of everything they do. Inquire about this opportunity and you could end up on a diverse and inclusive team where you’ll not only be valued but feel inspired to give your all to get the job done.
Minimum of a 4-year degree in relevant fields of study such as microbiology, chemistry, biology, or engineering. Three to five years of relevant work experience. Ideal candidates- Familiar with method validation tools- ie. MSAs and Gauge R&R. Should have experience with USP Testing Methods. Cell Culture testing- this individual will spend upwards of 70% of their time working on cell culture testing.
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
• 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
• 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
United States of America
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Job Title: Quality Engineer - Cell Culture Testing
Location: Manassas, VA
Job Type: Temp Position
Reference ID: 354632
Posted Date: 1/31/2019