Quality Engineer

Description:8am - 5pm EST (1st shift)Hybrid - must be local 4 days onsite and 1 day remote.This position performs various quality engineering functions and associated support tasks in developing knowledge and experience in the areas of Quality AssuranceDocument ControlDesign Control. This includes working to support Design Control projects as well as other duties in support of the Quality System, Design Control System, Document Control, Manufacturing, and the R&DProduct Development departments.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.• Represents the Corporation, Division and Quality Department in a professional manner.• Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.• Provides support for Project Teams or Quality Department as required such as generating RFS, ECR, PQR, etc. as required.• Creates and Reviews the following: Quality System Documents, Product Documents, Test Methods, documents required for Design History File.• Createsreviews Protocols, Process and Product Validations, Stability Protocols• Risk Assessments such as FMEA, FMECA or FTA.• Provides work direction as required.• Performs Internal or Supplier Quality System Audits.QUALIFICATIONS:The requirements listed in this section and below are representative of the knowledge, skill andor ability required:• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.• Ability to perform detailed engineering work under direction of a Senior Engineer or Quality Management.• May require consultation and direction to complete the key responsibilities..• Knowledge of manufacturing processes• Comprehensive knowledge of quality systems and relationship to business.• Experience in writing process, software, and equipment protocolsvalidations and has fundamental knowledge of validation principles.• Ability to participate on teams and maintain positive work environment with those teams.• Good communication skills (verbal, written, and presentation)EDUCATION andor EXPERIENCE:• B.S. in Engineering, Engineering Technology, Science a minimum.• American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.• Entry level position, experience with FDA regulated industry including experience with product development programs preferred.MATHEMATICAL SKILLS:• College level mathematical skills.• Basic applied statistics. kindly share resume at or call me at 678-935-7045 to discuss more.Contract W2 Only

Created: 2025-02-21