Join the GMED team today and work on the frontier of Medical Device Innovation!
GMED North America is looking for a full-time Operations Coordinator to join its team in the Bethesda’s office in Maryland. Working under the supervision of the Resources and Planning Unit Manager, the Operations Coordinator (B2B) will undertake many aspects of our evaluations’ preparation activities including but not limited to planning, proposal processing, service creation, inside sales, ensuring planned activities meet the objectives, analyze, prepare and convey timely documentation related to the services, and ensure communication and quality of service with clients.
- Ensures client commitment (contract, proposal, submission).
- Planning Technical File Review/Product Review services with technical teams (internal and external) and
- Ensures planned activities meet the quality and Operations requirements and objectives (profitability, revenue, timelines and workload).
- Monitors, analyzes report and improves all operational process steps from service feasibility, to documentation readiness and timely
- Monitoring, analysis, and reporting of External and Internal Reviewers productivity. Ensuring capacity fulfillment, monitoring and reporting (external/internal).
- Controls external Reviewers cost to meet the budget and profitability
- Forecasts and projects for Operations activities from the financial and productivity points of
- Ensures clear communication with clients, Reviewers and team members on all above
- Insures planning the activities is in line with the budgeted costs and the availability/capacity of the workforce assigned.
- Monitors, analyzes, reports, and improves process
- Performs other duties and responsibilities as required, requested, or delegated.
- Ensures up-to-date purchase order log for all external
- Proposals and cost management
- Plans, forecasts, and budgets invoicing activities in coordination with the internal teams involved
- Identifies monthly, quarterly and annual roadmaps, budget controls and reporting tools.
- Forecasts, monitors and reports external cost, external workforce utilization on a frequent
- Ensures an up-to-date status of the clients’ certification electronic files for the services planned within the scope of planning and confirmation of
- Communicates any workflow related alerts, errors, and deadlines to the Unit Manager and/or certification project manager in a timely manner.
- Updates of the Operations department databases (ERP, PROSIPAC, …etc)
- Prepares and conveys timely documentation related to the services including but not limited to; proposals, calculation sheet draft, purchase orders, cost
- Data recording, record keeping, archiving
- Ensures and coordinates with the financial department promptly and provides clear invoicing of the services and communicates with client regarding payment (within the scope of the services planned).
- Works closely with the technical, quality and regulatory teams to select the qualified personnel for the certification services.
- Ensures preparedness of documentation related to the position for internal and accreditation audits.
- Controls volume of services performed by each technical team member to satisfy the regulatory, quality and qualification requirements.
- Reports evaluation sending and filing on a frequent basis and ensuring communication with the different departments regarding the flow of records.
- Reports to the unit manager and quality manager incidents related to client dissatisfaction, quality anomalies and concessions.
- Attends staff meetings and various other meetings and takes minutes as directed by the unit manager.
- Commitments to client (response, availability, implementation, reactivity)
- Provides strong communication with the clients regarding their certification process status.
- Assures communication with the client regarding the additional costs incurred by the additional reviews to limit client dissatisfaction.
- Ensures a swift turnaround on client’s requests and questions utilizing the necessary tools and in collaboration with the relevant personnel.
- Identifies clients at risk, monitors and analyzes satisfaction and reports issues in a timely and constantly manner to avoid client loss.
Who You Are
Required Education and Experience:
- Bachelor’s degree in related field
- Excellent English (writing, typing and speaking) and good communicator
- Excellent command of Excel, word, PowerPoint and PDF
- 2 years’ experience in B2B client communication/sales of services
- Experience in planning and coordination of services
- Bachelor’s degree in engineering
- Able to travel if needed
- Experience in procedures and quality settings
- Preferred experience in medical devices
- Preferred experience in auditing/certification organizations
- French Language (writing, typing and speaking).
- Process orientated to deliver business success
- Sensitivity to detail with excellence in accuracy will be critical to job performance success
- Ability to handle confidential and sensitive information with the utmost professionalism
- Must be flexible and able to work independently and execute projects with minimal supervision
- Must be able to multi-task and complete assignments accurately and on time
Who We Are
GMED North America is the US subsidiary of GMED, a leading Certification Organization, a distinguished Notified Body (CE0459) whose scope covers all of the existing European Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC) and an Auditing Organization Recognized by the MDSAP Regulatory Authority Council. We serve the Medical Device Industry with offices in Europe and the United States.
Our goal is to provide the best in Product Certification and Quality Management Services for Medical Device Manufacturers worldwide. At GMED North America, we strive to the highest standards of professionalism, competency, work ethic, and customer service. All our employees are the cornerstone of this process because their work directly influences GMED North America’s reputation.
Aside from our expertise and due diligence, we pride ourselves in our diverse workforces, with employees from different parts of the World.
What We Offer
We offer a competitive benefits package including group-sponsored health, dental and vision coverage, short-term and long-term disability, 401k plan, company-paid life insurance, paid holidays and time off program providing our employees with great work-life balance. We offer growth opportunities within the organization. There are a lot of opportunities and employees are able to apply and move into different roles within the company. We have numerous success stories, and we want you to be one of them.
GMED North America is an Equal Employment Opportunity Employer, committed to a diverse, inclusive, and healthy work environment with a unique culture.
You are strongly encouraged to submit your resume and cover letter.