Join the GMED team today and work on the frontier of Medical Device Innovation!
The company is looking for a full-time Operations Coordinator to join its Bethesda’s office in Maryland. Working under the supervision of the Resources and Planning Unit Manager, the Operations Coordinator will undertake many aspects of our audits’ 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.
- Plans Audit services (onsite as well as documentary audit/reviews) with technical teams (internal and external) and clients including preparation of documents and mission assignments.
- Ensures the Unannounced Audit audits quota and selection is effectively communicated and discussed with the certification team and the Operations team members to meet the procedural and quality requirements.
- Monitors, analyses and reports of External and Internal productivity.
- Controls external auditor cost/expenses to meet the budget and profitability requirements.
- Ensures clear communication with clients, auditors and team members on all above activities.
- Ensures planning the activities is in line with the budgeted costs and the availability/capacity of the workforce assigned.
- Updates the purchase order log for all external workforce.
- Ensures the external cost is maintained under close control and meets the budgeted figures for the year.
- Communicates about any workflow related alerts, errors, and deadlines to the department manager and/or certification project manager in a timely manner.
- Updates the Operations department databases (ERP, PROSIPAC, Excel Sheets…etc).
- Prepares and conveys timely documentation related to the services including but not limited to; proposals, calculation sheet draft, purchase orders, cost sheet.
- Ensures and in coordination with the financial department, prompt and clear invoicing of the services, communication with client regarding payment (within the scope of the services planned)
- Works closely with the Certification, 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 to department 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 department manager.
- Ensures strong communication with the clients regarding their certification process status.
- Ensures communication with the client regarding the additional costs incurred by the Unannounced Audits, documentary audits and documentary 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.
Who You Are
Required Education and Experience:
- Bachelor’s degree or equivalent (engineers preferred)
- Minimum 1 year experience in project management and customer service
- Highly organized
- Planning and analytical skills
- Attention to details
- Proficient in Microsoft Office (Excel, words, PowerPoint, and outlook).
Who We Are
GMED North America is the US subsidiary of GMED, a leading Certification Organization, a distinguished Notified Body (CE0459) Authorized to act under European Regulation (EU) 2017/745 on medical devices, European Directives 90/385/EEC, 93/42/EEC, 98/79/EC and Regulation n° 722/2012 on products utilizing tissues of animal origin, GMED certifies a vast range of medical devices and in vitro diagnostic medical devices. 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.
- Commitment to Clients and Patients’ safety
- Team Work
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.
We look forward to hearing from you!