- PCI Pharma Services (Philadelphia, PA)
- …to identify patterns requiring systemic solutions + Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and other applicable standards ... understood and implemented + Support and participate in external audits including FDA , customers, and corporate audits **Team Development and Management** + Build,… more
- Envista Holdings Corporation (Quakertown, PA)
- …to FDA regulations/ISO 13485 requirements. + Experience with statistical software packages such as Microsoft Office tools. + Candidate must reside within ... the leading manufacturer and distributor of innovative dental imaging equipment, software , and solutions. We offer meaningful work through innovation, diverse… more
- Globus Medical, Inc. (Audubon, PA)
- …specifications for new product development + Creating and maintaining project plans and FDA compliant Design history Files (DHF) for each project + Managing all ... + Designing and developing instruments and implants using Pro/E software + Working with in-house prototype shop and outside...Assisting in the writing of regulatory applications to the FDA and other regulatory bodies + Coordination with the… more
- Globus Medical, Inc. (Audubon, PA)
- …+ Lead the design and development of surgical instruments and implants using CAD software (CREO). + Create and maintain project plans and FDA -compliant Design ... prototyping and evaluation. + Assist in writing regulatory applications to the FDA and other regulatory bodies. + **Customer Engagement:** + Obtain market feedback… more
- Globus Medical, Inc. (Audubon, PA)
- …specifications for new product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project + Managing all ... + Designing and developing instruments and implants using Creo software + Partnering with in-house prototype shop and outside...Assisting in the writing of regulatory applications to the FDA and other regulatory bodies + Partnering with the… more
- Globus Medical, Inc. (Audubon, PA)
- …design specifications for new product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project + Manage of all ... + Design and develop instruments and implants using Pro/E software + Partner with in-house prototype shop and outside...Assist in the writing of regulatory applications to the FDA and other regulatory bodies. + Collaborate with the… more
- Teleflex (Wyomissing, PA)
- …projects are developed and documented in compliance with the Quality System and with FDA and ISO standards. * Comply with Teleflex's Code of Ethics, all company ... Ability to perform basic statistical analyses using Minitab or equivalent software . Regulatory and Compliance: * Familiarity with design control processes,… more
- Legrand NA (Canonsburg, PA)
- …control practices comply with industry standards such as ISO 9001, FDA , and other relevant regulatory requirements. + Continuous Improvement Initiatives:Identify ... of document control systems and industry standards such as ISO 9001, FDA , or GMP. + Demonstrated leadership and project management skills. + Exceptional… more
- Fujifilm (Harrisburg, PA)
- …Speech Recognition tools, as well as actual dictation functionality when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Geisinger (Danville, PA)
- …+ Supports inspections/audits from regulatory/recommending bodies including TJC, PA DEP, FDA , ACR, and DOH. + Supports/oversees use of advanced medical imaging ... software including but not limited to patient dose tracking...Radiology (ACR) and United States Food and Drug Administration ( FDA ) definition of a qualified medical physicist (QMP). Certification… more
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