Medical Device Regulations

Siri InfoSolutions Inc

Posted on : 27-10-2024

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Job Location

Alexander City - USA

Salary

Not Disclosed

Salary Not Disclosed

Posted on : 27-10-2024

Job Description

Requirement ID: 9686436 Posted On: Oct232024 Role name: Engineer Role Description: NPI Validation IQ OQ PQ pFMEA and dFMEA Competencies: EIS : Medical Device & Regulations Experience (Years): 24 Essential Skills: NPI Validation Engineer3 years of medical device experience in NPI Windchill PLM Under limited supervision performs and documents moderately complex technical functions relating to test quality control layout fabrication modification and assembly of mechanical or electrical equipment and/or components. Experience in validation of product and equipment. Experience in New Product Introduction (NPD) with Solidworks. Knowledge of good manufacturing practices and documentation preferably in the medical industry. Risk management experience pFMEA and dFMEA. Knowledge on QMS NC CAPA and contribution in audits and ETQ instinct experience if any Preferably with knowledge of ISO 13485 FDA 21 CFR Part 820 and GMP. JnJ experience with ADAPTIV and Windchill PLM Oral and written communication in English.NPI Validation experience preferably knowledge in the medical industry. Desirable Skills: In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position: Identifies designs and develops the necessary equipment related to new product Introduction. Initiate Validation Master Plan for new projects Develop manufacturing process for new projects. Perform IQ OQ PQ protocol writing and validation activities. Guage R&R approach Studies the existing processes to implement improvements on new products. Perform NPI prototyping NPI project phase. Responsible for preparing and managing specifications. Performs activities of process/product validation. Manage the projects by conducting meetings tracking milestones define project plan. Responsible for communicating business related issues or opportunities to next management level. Performs other duties assigned as needed.Project Management experienceBachelor of Engineering any specialty. Country: United States Branch City Location: TCS Los Angeles
IRVINE
Irvine CA

Employment Type

Full Time

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About Company

Siri InfoSolutions Inc

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Medical Device Regulations

Siri InfoSolutions Inc

Job Description

Employment Type

Company Industry

Key Skills

About Company

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