Job Information
Quality Consulting Group Specialist Engineering in Villalba, Puerto Rico
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
Reports on the status of validation activities to fulfill regulatory requirements.
Performs investigation non-conformance events
Identify Corrective/Preventive Actions
Implementing Corrective/Preventive Actions
Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
Adapts machine or equipment design to factory and production conditions.
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.
Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.
Ensures processes and procedures are in compliance with regulations.
Work on the introduction on a new product.
Change control of Medical Devices
Qualifications:
Bachelor Degree in Engineering
Three (3) or more years of experience
Process Development and documentation
Equipment validation
SOP Development
Line layout and infrastructure and development
MES (Manufacturing Execution System)
Special Build Documentation and Line Support
Experience in equipment IQ
Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
Process Validation Lifecylce (from process characterization, operational qualification to performance qualification)
Preferred experience in DOE (with minitab)
Computer and software validation CSV
SOP Development
Change control of Medical Devices
MES system
Root Cause Analisys and Investigation
Availability for 1st 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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