Remote: Qms Sme (233782) Jobs
By Black Diamond Networks At United States

Job Description Our client is looking for a QMS SME with a background in pharmaceutical distribution for a 3 month assignment. This person will help to assess and approve SOPs, policies, and ...

Project Manager/Qms Jobs
By EG Life Sciences At United States
*Project management experience – PMP is a plus.
This is a 6+ month remote based project.
*Strong background in QMS based project for Medical device.
*Must be able to work West Coast hours
Medical Consultant Jobs
By The Triana Group, Inc. At United States
Perceived benefits and potential challenges related to the technologies we introduce
Review brief demos and provide feedback through online evaluation forms
Brief phone conversations to discuss your evaluations when needed
Hosting a Lunch & Learn session, if interested and feasible on your premises (optional)
Opportunity to join more in-depth studies, tests and other (optional)
Users and their current clinical methods
Andover Ma: Medical Device Quality Software Consultant – Onsite (233278)
By Black Diamond Networks At Massachusetts, United States
5+ Years of experience in design controls and risk management
Support Risk Management activities (RMP, HA, DFMEA, PFMEA, UFMEA and RMR).
Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements
Support safety assurance case creation in compliance with the regulatory requirements.
Performs other related duties and responsibilities, on occasion, as assigned
Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and ISO 14971
Associate Sales Consultant – Trauma - Medical Device Sales Support - Flagstaff, Az - Fya01765
By IQVIA At , Flagstaff, Az
OR 8 years or relevant experience in lieu of education requirement OR
Demonstrated planning, organizing and territory management skills
Experienced in data analysis and have excellent problem-solving skills
Knowledge of customer-focused selling skills
Knowledge of basic computer skills
Troubleshoot and provide other technical assistance; handle customer requests, effectively manage hospital billing, create / close purchase orders.
Medical Device Sales Representative (Therapy Consultant)
By Enterra Medical, Inc. At United States
Appropriately record and submit any product observations and/or complaints to the Enterra Medical Quality Management System.
Manage the company's resources within guidelines and governmental regulations.
Ability to travel between 50-70% of working hours and includes overnights, remote.
Open new Enterra Therapy programs, gaining alignment with implanting surgeons, referring gastroenterologists, other associated referring physicians, and supporting administrative teams.
Educate and train health care professionals on gastroparesis treatment, associated clinical data, patient selection, and appropriate implementation of Enterra Therapy.
Respond to customer needs, questions, and concerns regarding products and services.
Regulatory Consultant, Medical Device, Home-Based Usa - Iqvia Medtech
By IQVIA At , Remote $154,600 - $193,800 a year
Develops broader and deeper knowledge of consulting methodologies and MedTech market through on the job experience and training.
Sound knowledge of regulatory processes and requirements for all medical device and diagnostics classifications
Leverages business experience and acumen in identifying strategic alternatives and project approach to client questions.
Manages project teams/staff including both internal and external resources, when applicable, in the design, development and delivery of client deliverables.
May manage the process of proposal preparation and/or modifications including overall bid integrity.
Shares subject matter expertise with others to elevate our capabilities to deliver world-class solutions for clients.
Qms Administrative Assistant Jobs
By Gaming Laboratories International, LLC At Colorado, United States
We Offer Excellent Paid Benefits That Include
Strong multi-tasking, verbal and written communication skills are required.
Provide support for the Gaming Labs Certified mark program
Provide administrative support for GLI’s global QMS programs for gaming, voting and health IT
Provide administrative support for the GLI University program
Answers telephone, mail, and e-mail correspondence, providing general information and taking messages, as needed
Qms Manager Jobs
By Agilent Technologies At Atlanta, GA, United States
Minimum of 7 years supervisory experience (managing direct reports), including hiring, training, coaching and performance management activities
Act as the Training process owner and support implementation of a global Learning Management System (LMS).
Oversee preparation and provide direction on the content of Quality Management Review (QMR) in alignment with global standards and initiatives.
Minimum of 7 years professional experience in Quality in the medical device industry
Strong knowledge and understanding of standards and regulations: ISO 14971:2019, Regulation (EU) 2017/746, FDA CFR 21 Part 820, ISO 13485
Direct experience in managing QMS processes under above regulations
Sales Consultant - Medical Device Capital Equipment
By BAXTER At , , Mn $60,000 - $132,000 a year
Minimum three years of outside sales experience (medical device capital equipment experience preferred).
Durable medical equipment solutions selling preferred, O.R. integration experience is a plus.
Effective influencing skills –ability to understand the needs of, and influence, personnel ranging from nurses to C-level decision makers.
Outstanding communication, negotiation, organizational, problem solving, facilitation, and presentation skills are essential for success.
Territory: Minnesota, Wisconsin, South Dakota
Travel: Up to 50% overnight travel
Medical Device Qms Consultant
By Isometric Consulting Group, LLC At Michigan, United States
5–10 years of experience implementing and auditing medical device management systems
Coach the client on general quality management principles.
ISO 13485:2016 certifications are required.
Prepare DHf and biocompatibility studies.
Create the SOPs to support the activities for sales, import, distribution, etc. of the device.
Support the closure of internal and registrar audit findings.