QC Test Engineer, Systems - NeuMoDx - Ann Arbor
Do you have experience with QC testing of final production instruments and an eye for detail? If yes, and you have a functional understanding of cGMP's and cGLP, please read on!
Based in Ann Arbor, Michigan, NeuMoDx Molecular designs and develops revolutionary molecular diagnostic solutions for hospital and clinical reference laboratories. Its patented platforms offer market-leading ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve.
About the position
In this role, you will be responsible for QC testing of final production instruments. You will also assist in maintaining manufacturing equipment, train others, contribute to projects, and be trained to work in several areas as needed.
This role requires a self-starter, with the ability to work independently, understand of departmental goals, and work as a team to achieve those goals within set timelines.
About the role
- Perform QC testing of Final Instrument per procedures.
- Prepare and qualify Instrument using proprietary assays and reagents.
- Carry out work in accordance with defined Quality Management System procedures and be fully supportive of Quality initiatives.
- Support general Manufacturing objectives.
- Assist in maintaining manufacturing fixtures, calibrated tools, instrumentation, and manufacturing aids.
- Be committed to following and supporting safety practices.
- Prepare for testing by reviewing work orders, production schedule, studying and clarifying specifications; collecting materials and supplies. Set-up equipment necessary for different functional tests.
- Document final testing by completing applicable forms, reports, logs, and records equipment and batches using cGDP practices.
- Contribute to Continuous Improvement efforts; Identify and help implement process, procedure, and safety improvements.
- Complete and maintain training records within expected timelines.
- Train/mentor less experienced and new operators.
- Complete other tasks as needed.
- Functional understanding of cGMP's and cGLP, and the impact of deviating from controlled processes and/or procedures.
- College Degree (BS/BA) in science, mechanical, or software field plus 1-year relevant instrument production work experience or an Associate Degree and 2 years relevant work experience.
- Working knowledge and understanding of ISO13485, 21 CFR 820
- Some Leadership background - a plus.
- Software analysis background - a plus.
- Please send your resume to Info@AmyCellTalent.com - thanks!