- Merck & Co. (Rahway, NJ)
- …Expertise:Utilize extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to ... advanced degree (Master's or PhD) preferred.Minimum of 10 years of experience in medical device or combination product engineering, with at least 5 years… 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)
- …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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …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
- ZOLL LifeVest (Wichita, KS)
- …position Competitive fee for service Flexibility - work around your schedule Lifesaving medical technology The Cardiac Management Solutions division of ZOLL ... All candidates reviewed on an individual basis. Summary Description: The Cardiac Management Solutions division of ZOLL, manufacturer of the LifeVest(R), is seeking a… more
- Boston Scientific (St. Paul, MN)
- …of risk assessment methodologies, including the toxicological evaluation of medical device materials. Working knowledge of regulatory standards and global ... supported in progressing - whatever your ambitions. About the role: The Senior Medical Device Toxicologist at Boston Scientific provides technical support for… more
- Henry Ford Health System (Detroit, MI)
- …IPSO department and will work closely with other members of the SOC, IPSO ( Risk , Privacy, etc.), and IT programs to develop and implement a comprehensive approach to ... the management of AI security risks. PRINCIPLE DUTIES AND RESPONSIBILITIES: Lead AI security monitoring and incident response initiatives, with a primary focus on… more
- MEITHEAL PHARMACEUTICALS INC (Chicago, IL)
- …for Meitheal's Quality Operation processes including Complaint Investigations, Risk Management , Market Actions (eg, Field Alerts, Medical Device ... in market actions or product recalls, as needed. Leads Continuous improvement efforts and Risk management , as applicable. The salary range for this position is… more
- Appcast (Newport Beach, CA)
- …VSD closures)Promote preventive cardiovascular care through lifestyle counseling and risk factor management .Requirements:Completion of an advanced heart failure ... for production and quality-based bonuses based on performanceRobust benefits package: Medical , dental, vision, 401(k) plan with matchMalpractice and tail coverage… more
- Vivian (Oak Creek, WI)
- …end stage heart failure treatment (clinical work-up, left ventricular assist device implantation and heart transplantation).This is a high acuity fast-paced ... team members to coordinate patient centered care.Implements strategies to reduce patient risk and increase patient safety. Assesses patient and family readiness to… more
- L3Harris Technologies (Park City, UT)
- …Firepower Management Center (FMC), and/or Cisco ISE. Exposure to the Risk Management Framework, associated security controls, and STIGs. Familiar with ... and protocols including BGP, OSPF and EIGRP Experience with network device configuration and troubleshooting (ideally, Cisco IOS/IOS-XE with understanding of Juniper… more
- Cleared Jobs (Arlington, VA)
- Performs assessment and authorization coordination. Advises and assists the customer with Risk Management Framework (RMF) and develops a Plan of Action and ... information security, vulnerabilities, security controls, and threats to support organizational risk management decisions.* Identify, assess, and advise on… more
- Cepheid (Miami, FL)
- …quality systems activities related to assay development, specially design control and risk management activities in accordance with FDA and ISO regulations. ... other applicable global standards.Fulfill all quality planning, stability, and risk management deliverables with feedback from cross-functional...Quality with a focus on assay development in a medical device or IVD l industry with… more
- Cepheid (Miami, FL)
- …Medical Device Reporting globally. The role will collaborate closely with Medical and Scientific Affairs, Risk Management and Post Market Surveillance ... to make a compliant regulatory decisionDetermine reportability of complaints collaborating with Medical and Scientific Affairs, Risk Management , and other… more
- Leica Biosystems (Miami, FL)
- …and execution for external partnerships and product lifecycle management , ensuring compliance with global requirements and state-of-the-art standards.Maintain ... regulations on the development and registration activities for the respective medical productsDevelop and manage regulatory submissions (eg, 510(k), PMA, EU… more
- Abbott (Plano, TX)
- …for diversity, working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more ... disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives… more
- Beckman Coulter Diagnostics (Miami, FL)
- …international manufacturing environments.Deep expertise in quality systems and tools, including risk management , CAPA, APQP, PPAP, FAI, and statistical analysis ... plus if you also possess:Experience working in FDA-regulated industries or medical device manufacturing environments.Professional certifications such as CQE,… more
