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The Director, Quality Operations will be responsible to lead site-level Quality Control & Quality Assurance function activities, the Quality Management Systems (QMS), assure compliance to USA FDA GXP regulations across IVD products and all regulatory audit and inspection activities.
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This position may require licensing for compliance with export controls or sanctions regulations. This job role rotates employees through the disassembly of the engine, cleaning of the components, and inspection of the parts to prepare them for the next stage in production.
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Lead and manage the on-site construction team Coordinate and oversee all work on-site Attend production meetings Review and become familiar with schedule and budget, ensuring adherence to these Ensure quality standards are met Follow project timeline to ensure deadlines are met Monitor and ensure on-site safety compliance Maintain records and field reports Liaising with inspection authorities regarding approvals.
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Provide leadership as the main technical resource for corporate requirements and manufacturing staff as it relates to customer/regulatory requirements for food processing including, but not limited to, first, second- and third-party auditing and inspection, laboratory GLP’s (i.e. analytical testing protocols and methodologies), personnel safety, GMP compliance, and crisis management.
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Coordinate and direct Predictive Maintenance activities such as vibration analysis, ultrasonic inspection, thermography, and oil analysis. Electrical testing and motor current analysis, Leak detection, Corrosion monitoring, Process parameter monitoring, visual inspection/observations.
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Duties includes but are not limited to performing a variety of tasks associated with advanced technical building inspection and preliminary plans examining work; enforcing building codes, regulations and ordinances for both residential and commercial construction, and enforcing zoning ordinances related to historic preservation and/or urban design.
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Superintendent will be responsible for orderliness on-site and ensure compliance with safety regulations and quality standards. The Superintendent will also liaise with inspection authorities regarding approvals.
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Ability to use precision measuring instruments and make standard inspection set-ups. Inspector Primary Objective: To inspect and test a wide variety of purchased and manufactured parts to ensure compliance with pre-established specifications and quality standards.
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Direct involvement as IT lead for at least one FDA inspection & for multiple annual external audits of SOX IT General Control design & effectiveness, Segregation of Duties & SSAE-18 SOC Report reviews Multiple lab, scientific &/or financial software implementations (SDLC/Change Mgmt) as IT lead or compliance/validation lead.
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Routinely reviews backlogs and/or MI compliance reports to ensure all critical PM/PDMs and MI inspections are scheduled/completed within established time limits. Assist with Process Safety Management (PSM) compliance as it relates to mechanical integrity, engineering design, relief devices, process safety information, maintenance related procedures and all applicable document retention requirements.
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Total Safety is the world's premier provider of integrated safety and compliance services and the products necessary to support them, including gas detection, respiratory protection, safety training, fire protection, compliance and inspection, industrial hygiene, onsite emergency medical treatment/paramedics, communications systems, engineered systems design, and materials management.
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This role performs a variety of quality control tests/inspections on products, materials, components and parts at various stages of the production process to ensure compliance with quality and reliability standards, and to ensure effective inspection and testing procedures are implemented.
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Ensure product & process compliance per ASME Code and National Board Inspection Code requirements per ASME Code Quality Manual. 5 years as a Quality Engineer Knowledge and application of ASME code and National Board Inspection Code (NBIC) requirements Knowledge of 'U' pressure vessels, 'H' heating boilers, 'S' power boilers and power piping required.
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Lead a multi-disciplined team to manage and coordinate the detailed schedule, budget, ALARA and outage plan development and execution of Steam Generator Inspection & Repair ensuring technical specification compliance, quality and safety.
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Gallagher Bassett Technical Services (GBTS) division is seeking a "Construction Safety Loss Control Consultant" needed on a per assignment/quarterly basis in the San Jose - San Francisco - Sacramento, CA region to perform safety/loss control risk inspection on multi-year construction project located in the educational/university business sector.
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