US-CA-Irvine: Software and Computer Systems Validation
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Software & Computer Systems Validation
Plans and conducts software & computer system validation activities related to the manufacturing processes and products by performing the following duties:
Utilize Lean Six Sigma Black Belt tools to develop a disciplined approach to analyze the manufacturing process and product design to improve product quality, improve process capabilities, improve efficiencies and eliminate waste.
Plans and conducts the analysis, inspection, design, test and/or integration to assure the quality of assigned product or component. Writes and revises Quality System procedures as required.
Performs Quality Engineering reviews of design documentation for compliance with stated requirements, including Quality Manuals, GMPs and Quality Records.
Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
Provides Quality Engineering support for purchased products or components and provides input to the decision of whether to accept the product and future purchases from the vendor.
Manages/performs/assists in the validation qualification of new products and processes related to the manufacturing plant.
Documents data obtained during all quality assurance activities, consistent with company policies and procedures.
Develops new approaches to solve problems identified during quality assurance activities.
Participates in Audit related activities and implements corrective/ preventive actions.
Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
Prepares reports to communicate involvement and results of quality assurance activities.. Prepares and presents technical and program information to team members and management.
Prefer Bachelor degree from a four year college/university coupled with 5-8 years directly-related experience and working knowledge of 21CFR820 and ISO 13485 standards.
Six Sigma Black Belt Certification and Lean Manufacturing experience preferred
Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
Effectively operate in and may facilitate cross-functional teams with guidance.
Must be able to provide solutions that reflect understanding business objectives and cost implications.
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Team SQAFYI - Software QA Resource FYI