Average salary: $105,000 /yearly
More stats ...and engineers.
Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.
Understands and is aware of the quality consequences which may occur from the improper...
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Local area
...electronic training
Understanding of error analysis, uncertainty methods/calculations, statistical and quality control methods, and ISO requirements.
Summary Pay Range:
$79,680.00 - $119,520.00
Compensation and benefits offered may vary depending on multiple individualized...
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Holiday work
Flexible hours
...Office and Excel (v-lookups, charts, graphs, etc.).
Experience with Asana Project Management or related software
Familiarity with ISO or GMP regulatory compliance requirements
Previous experience working in a life science, biotechnology, and process manufacturing...
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...cleanroom environment: full gowning (full body coveralls, hood, CR safety shoes, face mask, nitrile gloves and safety glasses. Working under ISO 14000 standards).
* Operating/working around overhead cranes, fork trucks and motorized pallet movers.
* Working around lasers;...
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Immediate start
...identification of areas for process improvements.
Maintain lab notebook in a complete and consistent manner, following all legal, ISO, and QSR requirements, as well as keeping clear and complete.
Prepare reports and documentation providing the analysis or summarization...
Suggested
Local area
Night shift
...MIS systems, including Lab View and BAAN/ERP, to enhance manufacturing processes and efficiency.
Strengthen your understanding of ISO 9000 standards, ensuring compliance and quality across all operations.
Requirements
Qualifications:
A Bachelor’s degree in engineering...
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...of procedures/tasks according to established GMP under the direction of senior staff including manufacturing products within QSR and ISO regulations.
This position will be located onsite in San Diego, CA
The Responsibilities
Carries out production tasks in support...
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Flexible hours
...Good Laboratory Practice (GLP) guidelines.
Knowledge of quality policies, principles, and best practices, such as quality standards: ISO 13485, 21CFR Part 820, ISO 14971, or other appropriate industry standards.
Working knowledge of statistics to summarize data and...
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Work experience placement
Work visa
Flexible hours
...maintain a Secret US DoD security clearance.
PREFERRED SKILLS
Quality Management System (QMS) experience that is compatible with ISO 9001:2008.
REMARKS
Prior Navy experience a plus.
Must be able to communicate effectively in English, both verbally and in...
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Holiday work
Full time
Shift work
...Operates basic filling equipment. Maintains and archives Manufacturing log sheet records. Demonstrate processes during audits, including ISO, FDA and internal audits.
Qualifications:
~ High School Diploma or GED Required
~ Working knowledge of laboratory safety and...
Suggested
Shift work
Monday to Friday
...for panel physicians and appeals officers.
Perform quality reviews as requested by the client.
Serve as the medical expert in ISO and URAC audits.
Participate in quality improvement initiatives.
Report to Senior Director or VP level.
Minimum Requirements...
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...companies by Inc. Magazine (Inc. 5000)!
Tryfacta is certified by the Joint Commission for Healthcare Staffing Services & has numerous ISO Certifications that capture our commitment to continuous improvement.
Job Summary:
Tryfacta is seeking a Customer Service...
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...Systems Regulations (QSR) aspects of their position.
Ensures compliance with applicable Inova standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and all other...
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Worldwide
Shift work
...milling machines and operates six days a week. Argen's products are held to the highest standards of quality, and are FDA 510(k) cleared, ISO 13485 certified, and MDSAP compliant. Argen embodies a culture of innovation, continuous improvement, and LEAN practices in support...
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Monday to Friday
..., and maintaining equipment. The Manufacturing Associate II facilitates and executes daily production tasks with team members within ISO classified space.
How you will make an impact:
Reviews production schedule, studying and clarifying specifications, calculating...
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Local area
Work from home
.../or Experience
Bachelor degree in technical field or equivalent experience.
Minimum of three years related experience in a QSR/ISO, medical device, or similarly regulated environment. Interventional cardiology products manufacturing experience preferred.
Experience...
...teams develop clear roles and responsibilities to enable collaboration and accountability.
Emphasize quality and maintain/update ISO-9001 certification.
Develop and implement a root-cause Investigation program; instill a process to conduct root-cause investigation...
Holiday work
Full time
Contract work
For subcontractor
Monday to Friday
...Clinical study execution, policies, and procedures.
* You have expert knowledge of applicable regulations/standards training (i.e. ICH, ISO 14155, ISO 13485, 21CFR820, 21CFR812)
* You have CAPA Knowledge and experience.
* You have detailed knowledge of compliant...
Work visa
...maintain a Secret US DoD security clearance.
PREFERRED SKILLS
Quality Management System (QMS) experience that is compatible with ISO 9001:2008.
REMARKS
Must be able to communicate effectively in English, both verbally and in writing.
Must be able to...
Holiday work
Full time
...assist with the transfer of testing methodology to manufacturing.
~ Has working knowledge of federal and other regulations, e.g., QSRs, ISO 14971 IEC 60601 series.
~ Knowledge of Good Documentation Practices (GDP).
~ Integration experience in a manufacturing...
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Work visa
Flexible hours
...degree in Computer Science or related degree
Knowledge of IT aspects of common legal compliance programs such as SOX, HIPAA, CCPA and ISO
Experience with NIST 800 and CIS Top 20
Working Experience with Exchange, SAN, RAID a plus
COMPANY BENEFITS INCLUDE:
~...
Work experience placement
Summer work
...Regulatory Agencies, and in conformance with Good Manufacturing Practices, 21CFR Part 820, 21CFR Part 803, 21CFR Part 806, European MDR and ISO 13485.
YOU'RE AWESOME AT :
Provide strategic product direction to product teams and cross functional partners to advise on...
Holiday work
Worldwide
Flexible hours
...software skills, including Chromeleon, database management, Excel, python, R, etc.
Knowledge of standardized methodologies (ASTM/UOP, ISO, etc.)
Ability to work independently and to adapt to shifting priorities
Physical and Other Requirements
Ability to work at...
Holiday work
Flexible hours
Shift work
...design, and execution of product verification and validation activities throughout the product development life cycle according to FDA/ISO requirements and internal quality standards. This individual will be a hands-on subject matter expert to ensure the completion of V&V...
Local area
...recognize, evaluate and control physical, chemical, biological and ergonomic hazard
Safety and Environmental Management System, i.e., ISO 18001 and 14001 experience
Physical Demands and Work Environment :
Reasonable accommodations may be made to enable individuals...
Full time
Local area
Shift work
Day shift
...of experience designing, developing, and leading embedded systems or RTOS application software for medical devices.
Experience in ISO 13485 and FDA 21 CFR part 820 design control processes.
Demonstrated technical leadership for hardware development within the medical...
...design controls and an excellent working knowledge of medical device regulations and standards (21 CFR, EU Medical Device Regulation, ISO 13485, etc.).
* You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job...
Remote job
Relocation
Work visa
...a Secret US DoD security clearance.
PREFERRED SKILLS
Quality Management System (QMS) experience that is compatible with ISO 9001:2008 and 2015.
REMARKS
Must be able to communicate effectively in English, both verbally and in writing.
Must be...
Holiday work
Full time
Immediate start
Shift work
...initiation to the end of product commercialization
Monitor and ensure compliance to product development protocols within BioLegend's ISO 13485:2016 certified quality system.
Deliver progress reports
Taking inventory of received products within a BSL2 lab....
Full time
Temporary work
Part time
...communication skills.
# Understanding of the Software Engineering Institute (SEI) Capability Maturity Model Integration (CMMI) and ISO 9001 requirements.
# Ability to review, test, and evaluate the work of others.
# Proficiency in the use of basic office-related software...
Holiday work
Full time
Work experience placement