ECI · 13 hours ago
Supplier Quality Engineer - Entry Level #1229
Wilmington, DE
Full-time
Onsite
New Grad, Entry LevelECI is a global leader in professional consulting services for the life sciences industry, seeking a Supplier Quality Engineer to support their Global Supplier Quality organization. The role focuses on overseeing supplier materials and ensuring they meet regulatory standards through various quality control activities.
BiotechnologyConsultingLife ScienceProject Management
No H1B
U.S. Citizen Only
Responsibilities
Identify, segregate, and tag nonconforming supplier materials using approved tools (e.g., Nonconforming Material Tag QUA-4264-F01, Do Not Release Tag QUA-4262-F02)
Ensure nonconforming materials are clearly labeled, quarantined, and controlled to prevent unintended use
Provide accurate inspection data, photos, and records to Supplier Quality Engineers to support investigations, SCARs, SACAs, and NCEs
Process NCEs related to supplier materials per applicable work instructions and procedures (e.g., QUA-4264, QUA-4263)
Enter and maintain accurate NCE information (defect description, lot information, quantities, photos, traceability data) in Agile and other systems
Support Quality System Investigations (QSI) related to supplier issues by supplying data, samples, and documentation
Assist in executing and documenting NCE dispositions (e.g., return to supplier, rework, scrap, use-as-is) under the guidance of Supplier Quality Engineers and MRB
Identify when NCEs require corrections or rejection due to missing/inaccurate information and escalate appropriately
Help monitor NCE timeliness and status to support key performance indicators (KPIs) for supplier quality events
Execute raw materials sorting when related to an NCE
Execute isolation and containment steps for nonconforming supplier materials in MRB areas, both physically (material location, labeling) and electronically (system status, location codes)
Perform tasks to support MRB decisions (e.g., collecting samples, organizing material for inspection or return to supplier)
Ensure proper documentation of material status and movements related to MRB containment and disposition
Execute move order transactions for MRB, quarantine, and approved stock locations for supplier materials
Transact nonconforming materials to and from MRB locations in accordance with procedures
Retrieve material cost information to support NCE, MRB, and supplier performance analysis
Create, update, and complete NCE records associated with supplier nonconformances
Search for and review NCEs, QSIs, SCARs, SACAs, and other supplier-related quality records
Locate SOPs, Work Instructions, and specifications relevant to supplier quality tasks
Follow and comply with Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs) in all activities
Ensure all records (inspection forms, NCEs, MRB logs, Oracle transactions) are accurate, legible, complete, and timely
Correct controlled documents appropriately in alignment with procedural requirements
Maintain supplier-related quality records (as assigned) in accordance with applicable procedures
Support internal and external audits by providing documentation and demonstrating knowledge of relevant procedures and records, as requested
Work closely with Supplier Quality Engineers, Incoming Inspection, Manufacturing, and Purchasing to resolve day-to-day supplier quality issues
Provide data and feedback that contribute to supplier performance metrics, including defect trends and NCE statistics
Assist Supplier Quality Engineers in activities related to supplier containment, returns, and sorting
Support activities related to qualification or implementation of new suppliers or new parts by performing assigned inspection and documentation tasks
Participate in team meetings and follow up on assigned action items
Qualification
Required
Basic understanding of quality control and quality assurance concepts in a manufacturing or operations environment
Familiarity with measurement and test practices (e.g., calipers, micrometers, gauges, visual inspection tools)
Proficiency with Microsoft Office (Excel, Word, Outlook) for data entry, reporting, and communication
Must follow all applicable FDA regulations and ISO requirements as defined in the Quality Management System
Strong attention to detail and accuracy in inspection and documentation
Good communication skills, both written and verbal, with the ability to interact across functions and clarify requirements
Ability to analyze inspection data and identify trends or potential issues (with guidance)
Organized and reliable, capable of handling multiple tasks while meeting deadlines
Team-oriented, with a willingness to support engineers and peers and to share information
Proactive in raising questions or concerns when supplier materials or documentation do not meet expectations
Willingness and ability to learn and follow procedures, including training in the electronic training system before executing tasks
Preferred
Ability to read and interpret basic technical drawings, specifications, and inspection instructions
Basic knowledge of problem-solving tools and concepts (e.g., root cause analysis, basic statistics) is a plus
Experience with Agile and Oracle is desirable (can be acquired through on-the-job training)
Awareness of medical device regulations (e.g., 21 CFR, ISO 13485, ISO 9001) is a plus
Understanding of PPAP / APQP concepts or automotive-style supplier qualification is desirable but not required for entry level
Company
ECI
ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena.
Founded in 2012
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Michael Boyer
Chief Financial Officer
Shital Patel
Chief Operating Officer
Company data provided by crunchbase