- Merck & Co. (Rahway, NJ)
- …Decision Making, Dosage Forms, GMP Compliance, Inspection Readiness, Management Process, Medical Device Management , Medical Devices, Operational ... 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)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... Experience and Skills: Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination… 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
- 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
- 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. (North Wales, PA)
- …cross-functional impact, including drug device /combination products and software as medical device platforms.- Reviews and resolves issues that span diverse ... Building, Human Resource Management , Immunoassays, Immunology, Immunotherapy, Management Process, Medical Devices, Mentoring Staff, Ophthalmology,… 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
- 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 ... years of managerial experience. SPECIALIZED SKILLS OR EXPERIENCE * Risk Management experience in the medical device industry * Risk Management … 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 ...degree, and a minimum of 5+ years in the medical device industry or experience in a… 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
- 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...Certification * Experience with complex capital equipment or disposable medical devices or medical device … 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...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
- AbbVie (North Chicago, IL)
- …combination products. + Design, develop and deliver a comprehensive risk management program for pharmaceutical, combination and medical device products ... Minimum of 6 years experience with Quality Assurance and/or Quality System oversight. Risk Management and Device regulations experience is required. LINK-US… more
- Amgen (Cambridge, MA)
- … (ISO 13485); + Risk Management (ISO 14971); + EU Medical Device requirements (Council Directive 93/42/EEC); + Medical Electrical Equipment (EN ... various global manufacturing sites. This role requires a deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key… more
- Wolters Kluwer (Chicago, IL)
- …tasks or IT change requests in Service Now. + Support risk management /failure effect modes analysis (FMEA) activities for device software. + Drive change ... complaint trending, post-market surveillance, clinical evaluation, design control, and risk management activities. You will lead and... risk experience related to software as a medical device sold in the US, EU,… more
- Hologic (Newark, DE)
- …in quality tools such as PPAP, SPC, root cause analysis, and risk management . + Familiarity with medical device regulations and industry standards like ... product reliability and customer expectations. **Experience:** + 5+ years of experience in medical device manufacturing or a related industry. + 2-3+ years of… more
- Amazon (Seattle, WA)
- Description Lead Amazon's global Device Management Team (DMT) operations in a role that sits at the intersection of device innovation and operational ... opportunities and drive strategic initiatives. About the team The Device Management Team (DMT) is the operational...innovating to reduce lead times and costs. Through calculated risk -taking and scalable solutions, we maintain our position as… more
- HCA Healthcare (Nashville, TN)
- …Do you want to join an organization that invests in you as a Director, Sourcing Medical Device Management ? At HealthTrust, you come first. HCA Healthcare has ... you have the opportunity to make a difference. We are looking for a dedicated Director Sourcing Medical Device Management like you to be a part of our team.… more
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