Overview
Quality Engineer/Technician Jobs in Wilmington, NC at Compunnel Inc.
Title: Quality Engineer/Technician
Company: Compunnel Inc.
Location: Wilmington, NC
Title: Quality Engineer (w2 only)
Location: REMOTE
Hours: Monday – Friday, 8-5
Kindly, share resume on [email protected]
USC/GC/EAD/OPT
BS Degree in an engineering, scientific, or statistical field
Minimum of 3 years of manufacturing quality or related engineering experience.
0-2 years of experience in validation application.
In depth knowledge of applicable and similar industry requirements (e.g. ISO 9001, ISO 13485, ISO 15378 Quality Systems Regulations 21 CFR part 820, EU IVDR and MDR)
Knowledge of manufacturing processes and relevant statistical methods for quality assurance.
Support the standardization of quality engineering systems, architecture, and specifications across Division manufacturing facilities
Manufacturing Innovation Excellence (MIE) ,Manufacturing Scalability Playbook (MSP)
Other Performance Excellence (PEx) tools as appropriate (e.g. Six Sigma tools, FMEA, DoE, Measurement System Analyses, Gauge Repeatability & Reproducibility (R&R), DMAIC, Manufacturing Engineering Excellence (MEE), Lean, etc.)
Supplier Performance and Quality Management
Lead Quality projects of small scale and complexity
Participate in and sometimes lead Quality lead on projects of moderate scale and complexity
Supporting Quality lead on projects of sizable scale and complexity
Proficient on industry-relevant customer expectations (e.g. sterility, leachables/extractables, in vitro and in vivo toxicity, biological and chemical contamination sources and mitigation, etc.)
Support in the creation of technical documentation that fits business needs and maintains compliance to applicable international standard and regulatory requirements (e.g. ISO, FDA, EU, etc.)
