Join the GMED team today and work on the frontier of Medical Device Innovation!
Location(s): Rockville, MD (Hybrid)
Reports to: Resources and Planning Department Manager
Division: Operations
Position Classification: Non-Exempt, Full-Time
Fields: Medical Devices, In-Vitro Diagnostics - Healthcare
Job Description
The Operations Coordinator’s main mission is to plan and coordinate the execution of the assessment activities of certification projects. This position will provide project coordination and administrative support to several teams within the organization and will contribute to GMED’s development in terms of competencies and customers.
Values and Principles of the Resources and Planning Department:
In addition to GMED North America’s values (commitment to clients and patients’ safety, expertise, reliability, and teamwork), the resources and planning team members are driven by two principles:
- Passion for long term planning
- Taste for handling the unexpected
Essential Functions
Quality & Risk Management:
- Knows where to find the needed information in the QMS (procedures, forms)
- Applies internal procedures
- Informs senior colleagues or department manager of potential incidents related to quality standards
Production Planning:
- In charge of a customer portfolio for certification planning activities (audits, product reviews, and other related services)
- Applies the planning practices in place to meet compliance and operations requirements and objectives (revenue, timelines, and workload)
- Schedules the activities to maximize and optimize capacity utilization of GMED NA resources.
- Communicates clearly and precisely with stakeholders (clients, internal and external assessors)
- Informs senior colleagues or department manager of potential incidents or blocking points related to planning
Administration:
- Records accurate data and keeps the records updated in each planning department database (ERP, PROSIPAC, Excel Sheets…etc.)
- Maintains purchase order log for mandated external workforce
- Prepares and conveys timely documentation related to services including but not limited to, clients’ technical documentation, proposals, calculation sheet drafts, purchase orders, and cost sheets
- Maintains an up-to-date status of the clients’ electronic files on the S drive for the services planned within the scope of planning and confirmation of services
- Informs senior colleagues or department manager of potential errors related to workflow in a timely manner
- Coordinates with the financial department to deliver prompt and clear invoicing of the services, and communicates with clients regarding when payment is needed (within the scope of the services planned)
Contribution to GMED Development:
Qualification:
- Understands the supervision requirements and plans supervision activities
Client Satisfaction & Retention:
- Commits to clients (responsiveness, availability, implementation, reactivity)
- Ensures strong communication with the clients regarding their certification process status
- Ensures a swift turnaround on clients’ requests and questions utilizing the necessary tools and collaborates with the relevant personnel
- Identifies clients at risk, monitors and analyzes satisfaction, and reports issues in a timely and constant manner to avoid client loss
People & Planning Practice:
Team:
- May need supervision from senior Operations Coordinators on certain subjects
- Contributes to a positive working environment
- Shares experience and is seen as a team player
Planning Practice:
- Knows where to find the planning best practices
- Applies the planning best practices
Who You Are
Required Skills:
- Highly organized in a multi-tasking and milestone driven environment
- Detail-oriented
- Excellent written and verbal communication
- Proficiency with Microsoft 365 (Excel, Word, PowerPoint, Outlook, Teams)
Required Education and Experience:
- Bachelor’s degree
- 4 years’ experience in B2B client communication/sales of services
Expected Characteristics at the Resource and Planning Department:
Confidence: You build on being an authentic communicator. You stay positive with comments. You possess subject expertise. You speak about issues openly and do not hold back on information which might be relevant.
Easy to work with: You are proactive in seeking to provide assistance and support to your colleagues. You always show a positive and dynamic “can do” attitude. You relate to colleagues and offer support. You are flexible, dependable, and reachable to foster good working relationships.
Holistic: You keep yourself updated regarding the latest procedures, decisions, and developments in your customer portfolio’s field. You understand how your work is contributing to the overall success of GMED.
Trusted: You consistently complete tasks in a high quality and timely manner to show that you are reliable. You aim to be fully compliant with GMED’s guidelines, policies, and procedures to show that you strongly value GMED’s integrity and confidentiality. You raise issues early and openly if relevant and inform your manager
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 with due diligence, we pride ourselves in our diverse workforces, with employees from different parts of the world.
Our Values:
- Commitment to Clients and Patients' safety
- Expertise
- Reliability
- 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, a 401k plan, company-paid life insurance, paid holidays, a commuter benefits program for public transportation, internet stipend, and a time off program providing our employees with a 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.
We look forward to hearing from you!
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