- Zimmer Biomet (Englewood, CO)
- …compliance. * Assisting project teams on compliance with design control requirements per FDA QSR, European MDR, ISO 13485 and other applicable ISO/EN standards. * ... Accurately represents quality processes to 3rd party auditors ( FDA , ISO 13485, MDSAP, etc.). * Other duties as assigned. **Your Background** **Qualifications** *… more
- Medtronic (Houston, TX)
- …exhausted. This activity may include travel to sites to perform both system repair, validation , and data gathering + Validation of warranty claim submissions and ... in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or… more
- Stryker (Portage, MI)
- …Security Risk Assessments and defect management, software testing and/or verification/ validation . **Preferred:** + Bachelor's degree in Computer Engineering, ... Engineering, or Computer Science. + Experience with regulatory agencies ( FDA , MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with… more
- BioBridge Global (San Antonio, TX)
- …develop testing procedures according to organizational and regulatory (NMDP, AABB, FACT, ISO, FDA , and cGMP) standards. Assist with validation of all procedures ... advanced therapies. Leveraging its showcase facility designed to be compliant with FDA , EMEA, and PMDA production requirements, BBG Advanced Therapies focuses on… more
- Koniag Government Services (Silver Spring, MD)
- …regulatory applications and scientific reports, ensuring accuracy and completeness + Utilize FDA -provided Oracle or Access databases, or other computer systems, ... for data input as required + Perform data validation and quality control functions to maintain data integrity...+ Proficiency in using databases (eg, Oracle, Access) and computer systems for data input and management + Strong… more
- ABM Industries (Carlsbad, CA)
- …to the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. + Understands and is aware of the ... in their area of responsibility, including product design, verification and validation , manufacturing and testing activities. + Serve as system administrator,… more
- Katecho (Des Moines, IA)
- …operations, personnel management, and adherence to and administration of ISO 13485 and FDA , Title 21 Part 820, QSR. + Work with other departments to determine ... as required. + Assist in quality audits including, but not limited to, FDA , Customer Audits, Supplier Audits, and Internal Audits. + Serve as Quality technical… more
- Mentor Technical Group (Juncos, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system… more
- Charles River Laboratories (Shrewsbury, MA)
- …as appropriate. Serve as a Project Scientist for the development and validation of analytical assays. This individual would be responsible for the composition ... and execution of validation and sample analysis protocols/plan in accordance with company...required to talk, hear and work/ type at a computer . * Specific vision abilities required by this job… more
- BD (Becton, Dickinson and Company) (Holdrege, NE)
- …and system design, capital equipment acquisition, installation of equipment and validation support for projects. Provides leadership and training to less senior ... vendor liaison for the purchase, design, fabrication, installation, and validation of custom high speed automation equipment. + Provide...Title 180 _Control on Ionizing Radiation._ + Assist with FDA , ISO and NRC audits. In the event of… more
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