...of industry standards. Knows and follows the ISO quality system guidelines.
- Performs external vendor audits to ensure ISO and/or FDA compliance.
- Additional responsibilities may be assigned as needed.
Position Requirements
- Between 2-4 years of overall QA experience...
Suggested
...relevant HF & usability-related standards and guidance documents (ANSI/AAMI/ISO 14971, AAMI/ANSI HE75, ANSI/AAMI/IEC 62366, IEC 60601, FDA, etc.).
Demonstrate leadership skills
Strive to balance strategic planning and tactical execution.
Work with team...
Suggested
Local area
Work visa
Flexible hours
...manipulation, pushing and pulling.
Work requires the following motions: bending, twisting, squatting and reaching.
Exposure to FDA approved cleaning chemicals.
Exposure to temperatures: 90 degrees Fahrenheit.
Ability to work in a wet and cold environment....
Suggested
Holiday work
Full time
Traineeship
Immediate start
Flexible hours
Shift work
Night shift
All shifts
...manipulation, pushing and pulling.
work requires the following motions: bending, twisting, squatting and reaching.
exposure to fda approved cleaning chemicals.
exposure to temperatures: 90 degrees fahrenheit.
ability to work in a wet and cold environment....
Suggested
Holiday work
Full time
Traineeship
Immediate start
Flexible hours
Shift work
Night shift
All shifts
...experience as co-author for regulatory documents, CMC, and submissions.
Experience in working with regulatory authorities such as FDA, FDA-CVM, USDA, EMA, and/or Health Canada across all phases of clinical development and regulatory submissions for approval of biologic...
Suggested
...departmental metrics.
- Responsible for ensuring on-going compliance to applicable quality and regulations and standards (e.g., ISO, FDA, etc. as applicable).
Position Requirements
- BA/BS or equivalent scientific experience required with a minimum of 1 to 2 years...
Suggested
Full time
Second job
Relocation
Flexible hours
Shift work
Monday to Friday
...for better detection of disease and access to treatments. We operate a CLIA Lab in Boston and have launched COVID-19 PCR test under FDA EUA.
Currently only 1 out of 4 cancer treatment prolongs life, yet we spend $100 billion on drugs and 8 million patients die every...
Suggested
Immediate start
...verbal and written communication skills, excellent interpersonal, organization and problem solving skills.
# Working knowledge of FDA and other regulatory agency import/export regulations.
# Knowledge of inventory control practices, including demonstrated knowledge...
Suggested
...International Conference on Harmonization (ICH), and HIPAA guidelines
~ Strong understanding of U.S. Food and Drug Administration (FDA) laws and guidance on clinical studies
~ Strong working knowledge of IRB guidelines and Common Rule
~ Ability to manage competing...
Suggested
Temporary work
Local area
Remote job
Worldwide
Flexible hours
...manipulation, pushing and pulling.
work requires the following motions: bending, twisting, squatting and reaching.
exposure to fda approved cleaning chemicals.
exposure to temperatures: 90 degrees fahrenheit.
ability to work in wet and dry conditions.
ability...
Suggested
Holiday work
Full time
Part time
Work experience placement
Immediate start
Flexible hours
Shift work
Night shift
All shifts
$100k - $130k
...executing Human Factors Validation Studies.
-Strong understanding of Human Factors & Ergonomics, Design Control, PCA, ANSI/AAMI/IEC 62366, FDA, SolidWorks, Regulatory, Quantitative Data, Risk Analyses, and UI/UX.
-Familiarity with Medical Device standards such as 60601 & HE...
Suggested
Full time
Immediate start
...Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations.
Assist in the development and maintaining of process documentation including assembly procedures, test...
Suggested
Full time
Work experience placement
....
Requirements:
Bachelor's degree in a scientific or related field.
5 years of QA experience in cGMP and FDA inspection.
Strong communication and organizational skills.
Proficiency in Microsoft Office.
bility to work independently...
Suggested
...correct, and available prior to and during organic and gluten-free audits.
Successful relationships with stakeholders
USDA, FDA, GFCO, NOP, Customer, and other Identity Preserved Audits & due diligence documentation accurate, complete, available - first time,...
Suggested
...implementing a Quality Management System a plus.
•Knowledge of regulatory standards including ISO 13485 and/or ISO 9001. Knowledge of FDA QSRs a plus.
•Mango/Trackwise experience a plus
•Certified Quality Engineer a plus
•Experience in applying Lean...
Suggested
Weekly pay
Contract work
...dexterity, hand eye coordination and attention to detail.
**Skills:**
Mechanical, Clean Room, cleanroom, sew, tools, microscope, FDA, Medical, Tweezers, Assembler
**Top Skills Details:**
Mechanical, Clean Room, cleanroom, sew, tools, microscope, FDA, Medical, Tweezers...
Contract work
...attendance/PTO records and scheduling are maintained.
Responsible for Cardinal Health compliance and regulations concerning OSHA, DEA, FDA, State and local authorities; primary facility contact for QRA compliance and initiatives
Qualifications
~ High school diploma...
Temporary work
Local area
Relocation
Flexible hours
Shift work
Night shift
...including, but not limited to, The Joint Commission (TJC), National Fire Protection Association (NFPA), Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), Association for the Advancement of Medical Instrumentation (AAMI).
+ Documents all work...
Contract work
Local area
Remote job
Relocation
Monday to Friday
...Maintains an expertise in the selling, fitting and troubleshooting of current hearing aid technology.
* Comply with state license laws, FDA guidelines, WSA and Total Care Plus practice guidelines and QPG protocols.
* Provides remote services to clients as needed.
*...
Remote job
...manipulation, pushing and pulling.
work requires the following motions: bending, twisting, squatting and reaching.
exposure to fda approved cleaning chemicals.
exposure to temperatures: 90 degrees fahrenheit.
ability to work in a wet and cold environment....
Holiday work
Full time
Part time
Traineeship
Immediate start
Flexible hours
Shift work
Night shift
All shifts
...years of full-time teaching experience
~ Bachelor's Degree required
~ KIPP MA requires that all staff be fully vaccinated with an FDA or WHO authorized vaccine (or approved by KIPP MA for an exemption as a reasonable accommodation due to a medical reason or sincerely...
Full time
Summer work
Relocation bonus
...clearance in daily activities
• Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA regulations
Job Qualifications (minimum requirements):
• High School Graduate or equivalent manufacturing experience
• Must...
Permanent employment
...delivery team to elevate quality, service, and guest experience.
College degree preferred. Prior knowledge of aviation terminology, FDA Regulations, and food handling preferred.
Managerial business skills, including revenue-building, sales projections, sales...
Full time
Temporary work
New year
Local area
Worldwide
Flexible hours
...years of full-time teaching experience
~ Bachelor's Degree required
~ KIPP MA requires that all staff be fully vaccinated with an FDA or WHO authorized vaccine (or approved by KIPP MA for an exemption as a reasonable accommodation due to a medical reason or sincerely...
Full time
Summer work
Relocation bonus
...clearance in daily activities
10. Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA regulations
Skills:
Clean Room, Assembler, cleanroom, production, medical device, Medical, Medical assembly, microscope,...
Contract work
...lead efforts to mitigate those risks.
Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision...
Contract work
Work experience placement
Local area
...equipment
Will satisfactorily complete training and be responsible for Cardinal Health compliance and regulations concerning OSHA, DEA, FDA, State and local authorities
Support and contribute in the development and implementation of innovative modifications to processes...
Hourly pay
Full time
Temporary work
Work experience placement
Local area
Work from home
Relocation bonus
Flexible hours
Shift work
Night shift
Weekend work
3 days per week
Weekday work
...risk management.
Ensure Compliance with Regulatory Standards: Ensure that Design Controls adhere to IEC 62304 standards. Apply FDA and other regulatory knowledge and experience to risk management, software development, and testing.
Participate in Design...
...years of full-time teaching experience
~ Bachelor’s Degree required
~ KIPP MA requires that all staff be fully vaccinated with an FDA or WHO authorized vaccine (or approved by KIPP MA for an exemption as a reasonable accommodation due to a medical reason or sincerely...
Full time
Summer work
Relocation
Relocation bonus
Flexible hours
...equipment
Will satisfactorily complete training and be responsible for Cardinal Health compliance and regulations concerning OSHA, DEA, FDA, State and local authorities
Support and contribute in the development and implementation of innovative modifications to processes...
Hourly pay
Full time
Temporary work
Work experience placement
Local area
Work from home
Relocation bonus
Flexible hours
Shift work
Night shift
Weekend work
Weekday work
Monday to Friday