VTekis Consulting LLC provides complete solutions for Staff Agumentation, Recruitment Process Outsourcing, Contract Hiring, Direct Hire and Outsourced Solutions. Our goal is to deliver quality professional services to our clients not just to find someone to do a job, we match the right professional for your staffing needs and earning confidence through the proper assignment of people. This alignment of people and companies allows us to create opportunity. Most importantly, We don’t consider the process complete until we find the perfect fit.

Description:

• Engineering, Technical, or Scientific discipline with minimum of 5-8 years of related experience is required, preferably within a regulated environment (e.g. FDA regulated).
• Good Experience in IQ / OQ / PQ processes at Mfg sites
• Quality Engineering/Design or Process Excellence/Lean experience is preferred.
• Collaborate to complete Component Qualification, document evidence.
• Prepare Protocols, works requests & reports for Supplier Qualified components
• Collaborate with suppliers to collect evidence and/or develop Production Part Approval Process (PPAP)
• Knowledge of the QSR, Design Controls, and ISO quality requirements.
• Experience conducting Process / Design Failure Mode Effects and Analysis
• Understand and interpret all manufacturing audits, including ISO 13485 and other industry standards.
• Conduct supplier quality control audits on a regular basis to ensure vendors and their supplies remain in compliance with company and federal manufacturing and production standards.
• Experience in CAPA execution and Non-Conformance management
• Very Good in Oral & Written Communication
• Ability to work independently and partner with a cross-functional team (R&D, Regulatory, Manufacturing, and Purchasing)
• ASQ certifications are an asset
• Mechanical product knowledge is preferred. Problem-solving techniques including 8D, root cause analysis, and cause and effect analysis
• Knowledge in PLMs & ERPs like WindChill, ADAPTIV, AGILE, JDE, SAP

Regards,

Mohammed,

PH - 229-264-4029. Text - (770) 852-8474).

All your information will be kept confidential according to EEO guidelines.