- Merck & Co. (Rahway, NJ)
- …Forms, GMP Compliance, Inspection Readiness, Management Process, Medical Device Management , Medical Devices , Operational Excellence, People ... Job DescriptionRaw Materials & Medical Device Director, Small Molecule Analytical...role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as… more
- Merck & Co. (Durham, NC)
- …that manufacture, assemble, and test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical, ... goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …failures.Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)ICF reviews to ensure adequate disclosure for ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical data management and/or related industry work experience in a medical device , pharmaceutical, or biotechnology company, or similar environment (eg, ... requirements. This position requires experience working on multiple phases within the medical device and/or pharmaceutical industry in one or more complex… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …consistently and proactively represented at program level and support proactive quality risk management process.Interact with the audit and compliance function ... of MA risks identified through audits, inspections, internal meetings, remediation and risk management in close collaboration with the organization's quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant experience preferredData management and/or related work experience in a medical device or pharmaceutical company, or similar environment (eg, CRO) ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...this position has advanced skills in continuous improvement, project management , change management , and risk … more
- Merck & Co. (North Wales, PA)
- …Team Building, Human Resource Management , Immunoassays, Immunology, Immunotherapy, Management Process, Medical Devices , Mentoring Staff, Ophthalmology, ... cross-functional impact, including drug device /combination products and software as medical device platforms.- Reviews and resolves issues that span diverse… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in design (and resolution) of key ... an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, oversees and… more
- Merck & Co. (Rahway, NJ)
- …Design and Equipment Startup of Reactors, Dryers, Pressure Safety Devices , And Other Relevant Pharmaceutical Unit OperationsCapital Project Experience, Including ... to Schedule and Budget for Deliverables, Leadership of Teams, Vendor Management , And Demonstrated Communication With Senior LeadersAPI Small Molecule Manufacturing… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …and service conformance with particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), Production, Service Controls. Assuring ... experience in product development, manufacturing and / or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other… more
- Billings Clinic (Billings, MT)
- …assistance from internal or external sources as required to meet the needs of the Risk * Management Committee, Medical Staff, or others requiring risk ... Click here (https://billingsclinic.csod.com/ats/careersite/search.aspx?site=15&c=billingsclinic) to learn more! Clinical RN - Risk Management RISK MANAGEMENT… more
- Medtronic (Lafayette, CO)
- …manages and implements aspects of the Surgical Operating Unit's (SOU) Post-Market Risk Management of medical device products or software systems. * May ... experience. SPECIALIZED SKILLS OR EXPERIENCE * Risk Management experience in the medical device...with complex capital equipment or disposable medical devices or medical device software… more
- Billings Clinic (Billings, MT)
- …and assisting in coordination of medical malpractice claims at the direction of the Risk Management Director and/or the Risk and Claims Coordinator and ... sources as required to meet the needs of the Risk Management Committee, medical staff,...and/or serious patient/employee injury or death resulting from a medical device . Adherence to state and federal… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and post-production change management . Plan and execute the management of risk for medical device projects to ensure that risks are reduced ... Management process to conduct risk management activities for primarily post market device ...product teams to ensure that all hazards associated with medical devices are identified, the associated risks… more
- Medtronic (North Haven, CT)
- …in the early signal detection of field issues SPECIALIZED SKILLS OR EXPERIENCE * Risk Management experience in the medical device industry * Risk ... be assigned. * Serves as Subject Matter Expert for Risk Management across the Post-Market space for...with complex capital equipment or disposable medical devices or medical device software… more
- Sanofi Group (Cambridge, MA)
- …according to ISO 14971 and TIR 57 + Plan, prepare and perform risk management activities for medical devices according to project phases following all ... related activities. + Relevant experience in risk management for medical devices . +...of the following technical domains: + Medical devices and systems + Mobile device application… more
- Kestra Medical Technologies, Inc (Kirkland, WA)
- …+ Deep knowledge of embedded systems and software architecture, safety risk management , and medical device quality considerations + Commitment to extreme ... years of experience in the external and internal cardiac medical device markets. The company was founded...technologies, trends and clinical applications in the Cardiac Rhythm Management (CRM) industry COMPETENCIES + Ability to be a… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …ensuring the highest level of scientific rigor and compliance with global standards. + Risk Management & Medical Governance: Provides expert medical ... in medical affairs, clinical development, or a related function in IVD, Medical Device or Pharm 1+ year of experience in medical strategy development,… more
- Amgen (Thousand Oaks, CA)
- … System for medical device /component manufacturers - ISO 13485 Risk Management for Medical Devices - ISO 14971; EU Medical Device ... and regulated work environment + Background in development and commercialization of medical devices , and knowledge of manufacturing processes + Experience with… more
- Terumo Medical Corporation (Somerset, NJ)
- …+ Bachelor's Degree and a minimum of 10+ years of Enterprise Risk Management or related experience required, preferably in medical device ; or equivalent ... Director, Enterprise Risk Management Date: Jun 25, 2025...manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range… more
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