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...of a range of specialized medical temperature sensing devices for clinical and consumer... ...lines compliance with all Regulatory, Clinical and QA technical... ...to ensure conformity with quality specifications.
Participate... ...Strong knowledge of FDA 510 (k) and international...
Quality
Regulatory
Medical device
Work experience placement
...seeking a junior to mid-level associate to join our Medical Devices group of our Food Drug, Medical Device and... ...is also likely. Prefer experience with FDA device enforcement matters, postmarket compliance issues, quality systems requirements, recalls, adverse event reporting...
Quality
Medical device
Work experience placement
...employees.
VulcanForms Inc. seeks a Medical Device Software Quality Engineer for our Devens, MA location.... ...will be the subject matter expert of regulatory compliance requirements for... ...standards and regulations (including FDA 21 CFR Part 11, FDA General Principles...
Quality
Regulatory
Medical device
Holiday work
...Description
Description
The Manager Regulatory Affairs represents US regulatory affairs for device development projects. Executes... ...supplements and annual reports, FDA meetings) and potentially OUS... ...with operations, commercial, medical affairs, and marketing.
+...
Regulatory
Medical device
Holiday work
Temporary work
Local area
...the goal of transforming medical technology as we know... ...outcomes.
Job Title :
Quality Control Inspector 3... ...in accordance with the FDA, ISO, and other... ...environment for medical devices following Good Documentation... ...Engineering, Quality, and Regulatory Affairs.
Meet...
Quality
Regulatory
Medical device
Holiday work
Local area
...projects and initiatives that involve pediatric medical device development, evaluation of medical device regulatory landscape and health outcomes, and pediatric medical... ...devices in pediatric populations; 2) applying FDA medical device regulations to accelerate clinical...
Regulatory
Medical device
Full time
...the position of Director of Quality- Americas, and you will manage... ...objectives.
* You will ensure regulatory compliance to our SHS and CS... ...as Quality Manager in the medical device environment
* Knowledge of... ...device business (e.g. ISO 13485, FDA 21 CFR 820 QSR, EU MDR)
* 3+...
Quality
Regulatory
Medical device
Contract work
Local area
Worldwide
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...Experience providing high quality customer service to clients... ...Excel, Word)
Familiarity with FDA regulation and Quality Systems... ...able to commute to the Atrility Medical headquarters at least 3x per week... ...Logistics, Customer Support, Medical Devices, or Healthcare
Able to...
Quality
Medical device
Permanent employment
Local area
H1b
Flexible hours
...marketing.
Performed returned device evaluations.
Supplier... ...the Grand Avenue Software (GAS) quality management software platform.... ...in notified body, FDA, and internal audits, including... ...years applicable experience in medical device quality management systems...
Quality
Medical device
Remote job
...individual to fill the role of Regional Manager Regulatory Affairs & Quality Americas for our client, a global medical device company. The successful candidate will be... ...European Directive for Medical Devices and US FDA regulations is an advantage.
~ Preferably an...
Quality
Regulatory
Medical device
Holiday work
Local area
...We have an exciting opportunity for a medical device quality control specialist at Twin City Staffing... ...and external audits, preferably with FDA exposure.
Engaging in CAPA... ...of experience in a quality assurance/regulatory affairs background in medical devices,...
Quality
Regulatory
Medical device
Hourly pay
Immediate start
Flexible hours
Monday to Friday
...coordinate, author and review regulatory filing documents
3. Prepare US FDA submissions and CE Mark... ...510(k)
submissions, Device Master files, technical... ...landscape for medical devices globally, e.g. FDA... ...Provide in-house training on quality/regulatory related issues...
Quality
Regulatory
Medical device
Job Title: - Assembly Operator Location: - Plano, TX & Irving, TX Duration: - 1 year of Contract (With Possible Extension) Description:
~ Constant use of the microscope, perform a combination of assembly, repair, and test operat...
Medical device
Contract work
...A-Line Staffing is now hiring a Medical Device Quality Control Inspector in San Diego, CA. The Medical Device Quality Control Inspector would be working for a Fortune 500 company and has career growth potential. This would be full time / 40+ hours per week.
If...
Quality
Medical device
Hourly pay
Full time
Temporary work
Immediate start
Shift work
Afternoon shift
Monday to Friday
Design Assurance Engineer
Responsibilities:
Ensuring that the design process complies with relevant regulations and standards such as FDA guidelines, ISO standards, and other applicable regulatory ;
Working with the verification and valida...
Regulatory
Medical device
...Job Description
Sr. Quality Engineer (Medical Device)
Tucson, AZ (Relo available!)
Direct Hire. Onsite.
Talentry is looking for a qualified... ...ISO 13485, 14971, and 21 CFR 820, 803, 806, and other regulatory paradigms.
This Quality Engineer will develop and...
Quality
Regulatory
Medical device
...Job Description
Job Description Quality Engineer
ESSENTIAL FUNCTIONS INCLUDE... ...engineering support in the manufacturing of medical devices & hardware.
Ensure compliance of... ...knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485 as well other...
Quality
Medical device
...anywhere around the globe.
Position Summary:
The Quality Assurance Specialist III -Medical Device will provide advanced-level, hands-on support from a... ...departments regarding requests, release status, regulatory requirements and other tasks as requested
Work with...
Quality
Regulatory
Medical device
Worldwide
IntePros is currently looking for a
Quality Engineer, Medical Device Software development
to join one... ...multiple concurrent projects to ensure regulatory and quality compliance is maintained... ..., such as: IEC 62304, MDR 2017/745, FDA 21 CFR 820, ISO 13485, and ISO 14971....
Quality
Regulatory
Medical device
...for all aspects of QA for Medical Device and combination products manufactured... ....
compliance of establish Quality Management System (QMS) and... ...and all applicable FDA Part 4, Part 210/211, Part 82... ...7/745.
site readiness for regulatory agency inspections and/or Sun...
Quality
Regulatory
Medical device
Contract work
Flexible hours
