JT011 - MANUFACTURING ENGINEER II

• Change control of Medical Devices
• Equipment Commissioning / Qualification
• Process Validation
• Computer System Validation (CSV)
• Manufacturing, Packaging and Laboratory Equipment
• Technical experience (Trouble shooting) or any similar experience or background
• Quality / Process Control / Assurance of Medical Devices
• Design and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607-1 (Part 1: Requirements for materials, sterile barrier systems and packaging systems) and corresponding packaging ASTM and ISTA (International Safe Transit Association) standards.
• Validation of processes for packaging medical devices that are terminally sterilized as per requirements established by ISO 11607 2 (Part 2: Validation requirements for forming, sealing and assembly processes).
• These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

• Bachelor’s degree in Engineering 
• 3+ years of relevant experience.
• Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices
• Process Validation, Equipment IQ and Computer software validation knowledge
• Technical writing knowledge and Communication skills
• Investigation and root cause analysis skills
• Must have knowledge in Process Validation, Equipment IQ and Computer software validation.
• Provides technical and sustaining engineering support in a manufacturing area; therefore, investigation and root cause analysis skills are required to solve problems or improve effectiveness of job area (inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality).Good writing skills and communication skills in English and Spanish to have successful and productive meetings within a cross functional team
• Experiences with manufacturing processes creation / improvements
• Experience with process validations (IQ, PD, OQ, PQ)
• Special build coordination and follow up in manufacture.
• Shift: 1st shift and 2nd shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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