Search Results: 66 vacancies
...independently and take appropriate action in a timely manner.
· Knowledge of relevant industry standards (ASME BPE, USP VI, FDA, PED (EU), cGMP, BPOG) is a significant plus
Interested? If so, please apply directly to this posting!
Pay Details: $90,000...
Suggested
Holiday work
Temporary work
For contractors
Local area
Day shift
Monday to Friday
...facility
~ Prior experience working in a hands on, industrial role
~ Good mechanical aptitude
~ Solid understanding of GMP and FDA regulations
~ Must have good understanding of process flows and be able to read and review Process Specific P&IDs.
~ Ability to independently...
Suggested
Contract work
Night shift
Rotating shift
Day shift
...problems independently and take appropriate action in a timely manner. Strong interpersonal skills. Strong analytical and technical writing skills. Preferred Knowledge of relevant industry standards (ASME BPE, USP VI, FDA, PED (EU), cGMP, BPOG) is a significant plus...
Suggested
...controlled product development process.
* Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366, is preferred.
This position must meet Export Control compliance...
Suggested
Permanent employment
...of the Quality Management System (QMS) tailored to the biotechnology industry, ensuring compliance with regulatory standards such as FDA, EMA, and ICH guidelines.
One of your tasks will be to drive continuous improvement initiatives within the QMS, including CAPA, change...
Suggested
Holiday work
Contract work
Remote job
Worldwide
Flexible hours
...preferred.
Advanced training in project management and PMP, ACP, SAFe and/or Six Sigma certified strongly preferred
Knowledge of FDA, IEC and UL standards relating to medical devices.
Ability to interact with stakeholders at all level of the business with...
Suggested
Worldwide
...QMS), Environmental Management Systems (EMS), and other regulatory requirements.
•Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive...
Suggested
For contractors
Work experience placement
Shift work
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...fixtures to ensure functionality of new and existing features.
Ensures compliance with standards and regulations, including ISO and FDA QSR.
Ensures compliance with DICOM
Participate in all phases of product development as needed such as reviewing...
Suggested
...products, processes, and services.
Oversee the company's adherence to domestic and international regulatory standards, including FDA regulations, ISO standards, ASTM, and European Medical Device Regulation, for medical device design and development.
Lead the development...
Suggested
Holiday work
...QMS), Environmental Management Systems (EMS), and other regulatory requirements.
•Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive...
Suggested
For contractors
Shift work
...a cleanroom environment and provides our clients with crucial data to be able to maintain regulatory requirements (i.e., ISO, A2LA, FDA, EU, USP, etc.). In accordance with quality assurance requirements, the EM Technician I will independently gather and record test data...
Suggested
For contractors
Work experience placement
...estimates for supplies and equipment as needed.
Create SOPs as needed.
Responsible for all quality audits including PepsiCo, AIB, FDA, OSHA.
Responsible to ensure HACCP, GMP, Safety, OSHA, SOP's and all quality programs are being followed.
Responsible for all...
Suggested
Holiday work
Temporary work
For contractors
Local area
Shift work
Weekend work
Monday to Friday
...each complaint.
nalyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues.
Monitor and drive corrective action and...
Suggested
...are completed in accordance with applicable standard operating procedures and will ensure Distribution personnel follow all applicable FDA and cGMP procedures. Responsibilities include:
Responsibilities:
•Identifies and resolving issues with SAP warehouse management...
Suggested
Full time
...transactions are completed in accordance applicable standard operating procedures and will ensure Distribution personnel follow all applicable FDA and cGMP procedures. Responsibilities include:
Responsibilities:
Leads cycle count program, reviewing results and taking...
Suggested
Full time
Work experience placement
...in support of Quality Management Systems (QMS) and other regulatory requirements
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Six Sigma based...
For contractors
Local area
Relocation
Shift work
...Transportation (DOT), Environmental Protection Agency (EPA), Federal Motor Carrier Safety Administration (FMCSA), Food & Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), and Airgas safety standards (SAFECOR).
* Performs pre-trip and post-trip...
Local area
Day shift
...management system processes or critical business functions, in accordance with current applicable standards and regulations (including FDA 21 CFR Part 11, FDA General Principles of Software Validation and ISO 13485)
Manage and maintain non-product software validation...
Holiday work
...downtime activities.
Daily direction setting with facilities manager.
Maintain a cGMP compliant environment and operate within FDA guidelines for 21CFR820 manufacturing.
Diagnose and repair breakdowns, execute preventative maintenance tasks, and manage contractors...
Holiday work
Full time
For contractors
Shift work
Night shift
...associated with new equipment.
Oversees change control associated with modifications to existing equipment.
Ensures compliance with FDA, OSHA, and other regulatory agencies as appropriate.
Supervises and directs contract personnel and outside vendors in the...
Full time
Contract work
Temporary work
Local area
Immediate start
Worldwide
