Search Results: 62 vacancies
...improvement
- Manage projects related to quality assurance, including planning, execution, and monitoring
- Ensure compliance with FDA regulations and CGMP (Current Good Manufacturing Practices)
- Provide guidance and support to the Quality Control team in...
Suggested
Full time
...In this role, you will have the opportunity to:
Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements.
Work directly and in coordination with cross-functional team members to tackle problems...
Suggested
...through coaching and mentoring. Maintains a safe and professional work environment
Comply 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
...over 100 distributors worldwide. The Regulatory Affairs Specialist will focus on assisting with maintaining product compliance with FDA/MDSAP, ISO, and MDD/MDR requirements. We are looking for an excellent communicator and highly organized individual to join our team on...
Suggested
Worldwide
Shift work
...assurance tasks to ensure the consistent delivery of high-quality documents, services, products, and processes.
Maintenance of FDA/MDSAP, ISO, and MDD/MDR compliance
Work with Engineering and Quality Departments in product development to ensure compliance throughout...
Suggested
Worldwide
Shift work
...also meet regulatory requirements and follow company policies and procedures. Candidate should have a willingness to work in an ISO9000/FDA regulated environment.
The position reports to the Manager, Development Science and is based in Chaska (Minneapolis), MN.
You...
Suggested
...is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record...
Suggested
Holiday work
For contractors
Local area
Shift work
...protein purifications and/or conjugations using good laboratory practices; assistance in other areas as needed
Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements
Apply basic analytical...
Suggested
...supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971. Solid communication and interpersonal skills. Strong project management and leadership skills, including...
Suggested
Work experience placement
Shift work
...also meet regulatory requirements and follow company policies and procedures. Candidate should have a willingness to work in an ISO9000/FDA regulated environment.
The position is part of the Reagent Development Department located in Chaska (Minneapolis), MN and will be...
Suggested
...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
...Management System (QMS), including development and maintenance of documentation
Develops products that meet requirements regulated by FDA, EU regulatory body, PMDA and other governing bodies as defined by product management.
Commit to fostering and driving an...
Suggested
.... cost, material, time, etc.), user-friendly manufacturing processes.
Comply with appropriate regulatory agencies (i.e. GMP, ISO, FDA, etc.) and associated quality systems described in PMT's documentation.
Communicate with strategic vendors and suppliers.
QUALIFICATIONS...
Suggested
Day shift
...foods processing and packaging
Food safety and sanitation principles (GMP, SQF)
State and Federal rules and regulations (USDA, FDA, OSHA, etc.)
Knowledge of plant operations and production scheduling
SKILLS IN:
Supervising personnel in a manufacturing environment...
Suggested
Holiday work
Temporary work
Gangs
Shift work
Night shift
...to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured...
Suggested
Interim role
Flexible hours
Weekend work
Afternoon shift
...are complying the U.S. requirements.
Works with Product Management to define/plan which applications or changes would require new FDA submissions.
Prepare FDA submissions for new HIT products and HIT product changes to ensure timely approval for market release in...
Casual work
Work alone
Flexible hours
...project management.
~ Strong motivational leadership skills and the ability to influence others without direct authority.
~ ISO and FDA regulated environment experience is recommended.
~ Ability to travel (domestic and internationally) up to 10% of the time....
Contract work
Work experience placement
...computer / MS Office skills
It would be a plus if you also possess previous experience in:
Experience working in regulated (FDA preferred) company environments
Mastery of a variety of Lean tools
At Beckman Coulter Diagnostics we believe in designing a better...
Part time
Remote job
Flexible hours
...public health and safety measures, EXOS requires that all successful applicants shall be required to show proof of full vaccination by an FDA-approved COVID-19 vaccine before beginning employment, unless an exemption from this policy has been granted as an accommodation or...
Local area
Worldwide
...Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes, consulting as needed with management.
Prepares...
For contractors
Worldwide
Shift work
