- Edwards Lifesciences (Irvine, CA)
- …project execution and compliance with internal and policies and procedures (QSR, FDA Regulations, and ISO Standards). * Partner and support product development ... efforts in the design and iteration of new delivery systems, and components for transcatheter tricuspid valve replacement technologies. **What you'll need (required):** * Bachelor's degree in a related field (Engineering, Applied Sciences, Etc.) and experience… more
- Colgate-Palmolive (Emporia, KS)
- …assessments as required to meet all GMP's, Food and Drug Administration ( FDA ) and AIB requirements. + Responsible to support line operations during lunches, ... breaks and coverage for open positions. + Responsible for finished goods preparation and inspection, including top cap placement, inspection checklist, legible date codes, and quality of bag seals. + Production line waste removal and disposal according to… more
- Penn Medicine (Philadelphia, PA)
- …with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, etc) Manage the day-to-day planning, operations and problem solving for ... assigned areas - ensure daily schedule, staffing needs, and performance metrics are met. Communicates changes appropriately. Develops and maintains APM templates and master schedules Oversight of AHIQA. Runs regular financial reports and works towards… more
- Merck (West Point, PA)
- …can interact effectively with leadership. + Strong understanding of CGMPs, FDA , and EMEA regulatory standards and strong compliance mindset; comprehension and ... use of these standards is to support the compliance and eventual sustainment of ongoing large-scaled projects, as warranted. + Demonstrated leadership and management experience working with cross-functional teams on objectives to deliver on Key Performance… more
- Globus Medical, Inc. (Memphis, TN)
- …in ASME Y14.5M and blueprint reading + Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO ... 13485 **Travel and/or Physical Demands:** + Required to sit; climb or balance; and stoop, kneel, crouch or crawl + Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds + Required to possess specific visons… more
- Astrix Technology (New Brunswick, NJ)
- …and bioprocess equipment support. + Working knowledge of GMP, FDA , and biopharma-regulated environments. + Strong analytical, diagnostic, and problem-solving ... skills. + Effective communication and teamwork abilities. + Ability to work flexible hours, including nights/weekends if required for operational needs. ** **_This job description is a complete list of all desired skills but not all are required. We strongly… more
- GE HealthCare (State College, PA)
- …instruments (micrometers, calipers, CMMs). + Maintain documentation in compliance with FDA , ISO 13485, and GMP standards. + Collaborate with quality assurance ... and engineering teams to ensure product conformity. + Maintain a clean and organized work area, adhering to cleanroom protocols when required. + Troubleshoot machining issues and suggest process improvements. + Experience with CAD/CAM/Mastercam software. +… more
- Avispa Technology (Tucson, AZ)
- …Familiarity: Experience working in a regulated environment, with familiarity with FDA , ISO, and other relevant regulatory standards for diagnostics products, ... especially regarding requirements, risk, and validation. * Strategic Mindset: Demonstrated interest in innovative technologies and understanding of the competitive landscape in IVD, with an eye for potential risks, critical requirements, and robust validation… more
- BHI Energy (Reno, NV)
- …general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA Regulations. + Identify and report any product quality problems + ... Facilitate resolution of the non-conforming product until the deficiency or unsatisfactory condition has been resolved Job Requirements Education and Experience + 1 or more years assembler experience in the medical device field or a related technical field +… more
- Bristol Myers Squibb (Indianapolis, IN)
- …experience . Pharmaceutical and GMP experience preferred. . Experience working with FDA or other federal and state regulatory bodies. **Skills and Qualification** . ... Highly motivated and organized professional with the ability to work independently. . Working knowledge of 21 CFR Parts 11, 210, and 211 . Very personable with strong communication skills . Excellent professional ethics, integrity, and ability to maintain… more