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Production Coordinator

Join the LNE/G-MED team today
and work on the frontier of Medical Device Innovation!

Location(s): North Bethesda, USA

Contract Type: Perm Full-Time

Fields: Medical Device – Healthcare

Salary: Competitive Salary

 

About G-MED North America, Inc

G-MED NA is the North American subsidiary of the National Metrology and Testing Laboratory, LNE, a leading Certification Body established in 1901. We serve the Medical Device Industry with offices in Europe and the United States. Our goal:  Provide the best in Product Certification and Quality Management Services for Medical Device Manufacturers worldwide.

In addition to our CE marking, ISO 9001:2015 , ISO 13485:2016 and MDSAP certification services, LNE/G-MED is accredited by the Standards Council of Canada SCC under the Canadian Medical Devices Conformity Assessment System CMDCAS and is an Authorized Organization for the Medical Device Single Audit Program MDSAP. Our full range of technical conformity services, from Diagnostic audits to Training services, allows the convenience and efficiency of a local based team of Technical Experts, Assessors, Auditors and Certification Program Managers.

LNE/G-MED North America is an Equal Employment Opportunity. We offer excellent benefits package including a group-sponsored health, dental and vision coverage, short-term and long-term disability, a company-matched 401k plan, a company paid life insurance, paid holidays and time off.

About the Production Coordinator  

We are currently seeking a Production Coordinator in North Bethesda, (MD) who is passionate about Detail, Organization and supporting a team in our high-energy growth oriented company.

The Production Coordinator main mission is to oversee in details the contract certification and certificate issuance process for technical file/design dossier evaluations and quality management system audits. This position will provide office and clerical support to several teams within the organization.

The successful candidate will comply with LNE’s procedures, processes, policies and actively:

  • Maintain at all time updated client information’s on the local and HQ databases (ERP software, Production Planning etc.)
  • Draft, record and monitor regularly certificates in Certificate database to guarantee their permanent validity and accuracy  
  • Participate in the certification contract drafting, recording and status monitoring
  • Report incidents or anomalies related to client satisfaction to Production Director according to procedures in place.

The ideal candidate will act as the time keeper for the certification process and:

  • Plan files for certification committee in coordination with the different departments and Headquarters
  • Prepare mission orders and assignments for technical file/design dossier evaluations and quality management system audits to be validated by Certification Project Managers
  • Ensure processing of certification committee results are performed within the accepted and procedural timelines as defined in the Quality Management System.

About the candidate’s profile:

  • Process orientated to deliver business success
  • Sensitivity to detail with excellence in accuracy will be critical to job performance success.
  • Excellent writing, editing and time management skills
  • Possess interpersonal skills, both oral and written, and the ability to work well with all levels of internal and external management and staff
  • Demonstrated executive presence through professional presentation and support a very professional environment. 
  • Ability to coordinate and participate actively in meeting presentation and events (including clients’ visit and conference)
  • Experienced in Microsoft Office Suite (Outlook, Word, Excel, and PowerPoint)
  • Ability  to handle confidential and sensitive information with the utmost professionalism
  • Desire to develop skills and ability to quickly learn new technology 
  • Must be flexible and able to work independently and execute projects with minimal supervision. 
  • Self-motivated to handle and/or delegate initiatives in Production Director's absence. 
  • Must be able to multi-task and complete assignments accurately and on time

About the degree requirements:

  • Administrative professional associate's degree or equivalent degree from a foreign school that provided education and knowledge substantially equivalent to accredited schools in the United States, Canada or Europe
  • At least 2 years of experience in an administrative or secretarial position 
  • Fluent English language skills essential and French literacy (must be able to read and understand French procedures, peer review documentation in French etc.)
  • Must be literate in the use of MS Office applications
  • Authorized to work in the US

This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts together with a resume. 

 


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We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

   1-301-495-0477

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Due to rapid growth in North America, we're seeking Lead Auditors, Medical Device Clinical Expert, Production Coordinator , Certification Project Manager Active and Non-Active Medical Device responsible for medical device manufacturing clients.