Overview
Senior Quality Manager Jobs in Fort Worth, TX at KPS Global, LLC
Stefanini Group is hiring!
Stefanini is looking for Quality Engineer in St. Paul, MN
For quick Apply, please reach out to Gurvinder Singh Bali – call: 2482638629/ email: [email protected]
Work Hours: M-F (40 hours)
Work Location: St. Paul, MN
Shift: 1st Shift
As a Quality Engineer, you will provide Quality Engineering support to manufacturing and new product development teams through Engineering Investigations, Qualifications and Validations. In this role you will identify quality issues, participate in quality improvement projects and quality activities that impact manufacturing. Additional responsibilities will include maintenance of on-going stability validations, nonconformance investigations, maintenance of risk management documentation, and corrective and preventive actions when required.
Responsible for NCR and CAPA activities. Investigate and disposition nonconforming material reports (NCR events). Initiate, investigate, and implement corrective and preventive actions as assigned. Perform internal quality system and supplier audits, as assigned.
Responsible for preparation of written Engineering Investigation, Qualification and Validation plans, statistical analysis of data and preparation of reports to support manufacturing improvements, on-going validations, and new product development efforts.
Support product development teams to develop new products and transfer to manufacturing through participation/leadership of risk management activities, performance of component qualifications, and execution of test protocols.
Responsible for coordination of validation activities performed by outside contract services to ensure adherence to specifications and expectations.
Initiate documentation or documentation changes (DCRs, Deviations, etc.) for products and processes as required to reflect validation/qualification activities and results.
Other duties as assigned.
BS in Engineering or related field of science.
1+ years of experience in Manufacturing Quality, Design Assurance or Quality Systems.
Experience managing non-conformance activities and owning corrective and preventative actions.
Must have the ability to read/interpret design prints.
Working knowledge of FDA GMP and ISO 13485 requirements.
Knowledge of statistics and quality tools such as SPC, Risk Analysis, Process Capability, DOE, TQM methods, and Lean/Six-Sigma.
Preferred:
Sterilization and Process Validation experience.
ASQ Certification in Quality Engineering.
Previous Quality System auditing experience.
Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.
Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.
About Stefanini Group
The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.
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Title: Senior Quality Manager
Company: KPS Global, LLC
Location: Fort Worth, TX
