- Medtronic (Minneapolis, MN)
- …every stage of development leveraging Waterfall and Agile Development methodologies. US FDA Quality System Requirements, ISO 13485, ISO14971, IEC 60601, and IEC ... 62304, 21CFR 820 (Code of Federal Regulations). *Position is open to telecommuting from anywhere in the United States. #LI-DNI. **Basic Qualifications:** Bachelor's Degree in Information Systems, Software Engineering, Computer Science, or related technical or… more
- Bristol Myers Squibb (Devens, MA)
- …industry, preferably with 2+ year of deviation experience. Experience in FDA /EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. + ... Demonstrated experience with electronic system and databases. + Demonstrated proficiency in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc. If you come… more
- ICON Clinical Research (Winston Salem, NC)
- …of pro-active behaviors. + Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit. + Ordering ... clinical supplies, as well as ordering, storing and monitoring of protocol specific rescue drugs and maintaining scheduled assessment of the code/crash cart and AED including maintaining proper documentation for both. + Monitoring and maintaining… more
- Sysco (Vernon, CA)
- …years meat and/or seafood industry (as appropriate) experience at a federal CFIA/ FDA meat and/or seafood processing plant (as appropriate). Knowledge of meat, ... poultry and/or seafood products including product specifications. Experience as a Quality Assurance or Quality Control Technician in a meat or seafood processing is desirable. **LANGUAGE SKILLS:** Incumbent must demonstrate ability to write reports, basic… more
- GE HealthCare (Arlington Heights, IL)
- …and Unscheduled Work Orders based on calibration and PM findings that may receive FDA review. + Ability to pass all gown qualifications is required to perform work ... in manufacturing clean room environments. + Responsible for compliance with radiation safety procedures, including individual dose management. + Work closely with outside manufacturing and facility/equipment support contractors. + Complete all planned EHS,… more
- Bristol Myers Squibb (Princeton, NJ)
- …exposure to current Good Manufacturing Practices (cGMP), Food and Drug Administration ( FDA ) and other regulatory requirements. + Exposure and experience in Biotech / ... Pharmaceutical manufacturing processes, principles and practices. + Business Systems Owner. Drives the departments overarching digital strategy. Identifies and champions emerging technologies (eg, AI, automation) that can create a competitive advantage and… more
- Abbott (Altavista, VA)
- …documentation You'll be accountable for meeting our compliance standards including FDA , OSHA and Abbott policies and procedures. **Required Qualifications** + High ... School Diploma or GED + Understanding of mechanical systems + Mechanical and spatial aptitude + Good math and writing skills + Knowledge of hydraulic and fluid systems as well as proper lubrication procedures with oil and grease **Preferred Qualifications** +… more
- Penn Medicine (Exton, PA)
- …with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) Change Management: + Flexible and readily ... adopts new processes and is engaged in practice operation changes. Education or Equivalent Experience: + HS Diploma/GED AND 2+ years medical office experience OR 2+ years customer service experience required. Advanced degree (Associate, Bachelor, Master) may… more
- Olympus Corporation of the Americas (Westborough, MA)
- …technically complex new product development programs. + Experience with applicable FDA guidance, ISO 13485 regulations, and applicable industry standards. + Position ... requires up to 20% domestic & 5% international travel. + Effectively demonstrated planning and organizational skills with background and experience in project management principles, practices, techniques, and tools. + Must be able to work independently and be… more
- Owens & Minor (Alpharetta, GA)
- …System Regulations (Design Control and Process Validation) compliant with the FDA and other regulatory agencies + Previous experience resolving technical issues ... and implementing solutions + Ability to lead and manage small to medium scope projects + Ability to interface effectively with health care professionals and medical device customers + Ability to travel both domestically and internationally up to 20% (must have… more