Certification Coordinator

Join the GMED team today and work on the frontier of Medical Device Innovation!

Location(s): North Bethesda, MD or Remote from Home

The Certification Coordinator’s main mission is to oversee and process in detail quality management and CE audits, evaluations, and certification processes. This position will provide coordination and administrative support to several teams within the organization.

ESSENTIAL FUNCTIONS

A successful candidate will comply with GMED NA procedures, processes policies and actively:

• Maintain client information updated at all times on the local and HQ databases;
• Draft, record, and regularly monitor certificates in the database to guarantee their permanent validity and accuracy;
• Draft documentation, record, and monitor the certification process pre-service and post-service phases;
• Communicate with clients, auditors, and the certification team to optimize the certification process;
• Report all the requests related to client satisfaction to the direct supervisor or certification director according to the procedures;

The ideal candidate will act as the timekeeper of the certification process and:

• Prepare mission orders and assignments for technical file/design dossier evaluations and quality management system audits to be validated by certification managers;
• Prepare files for certification committee in coordination with the different departments and headquarters;
• Ensure processing of certification committee; results are performed within set procedural timelines as defined in the Quality Management System;
• Ensure proper service follow up and closing according to the QMS procedures and accreditation requirements;
• Report activities in a consistent and frequent fashion to identify trends, corrections and capitalize on strengths.

WHO YOU ARE

Required Education and Experience:

• Bachelor’s degree or equivalent degree from an accredited U.S. or foreign university
• Experience in project coordination and/or experience in an administrative or secretarial position required
• Fluent English language skills essential (French is a plus)
• Advanced MS Office skills (data analysis/programming skills a plus)
• Authorized to work in the U.S.

Job-Specific Competencies:

• Able to deliver business success
• Attention to detail with excellence in accuracy will be critical in job performance
• Possess interpersonal skills, both oral and written including the ability to effectively communicate with other employees and clients
• Excellent writing, editing, and time management skills
• Advanced skills in Excel reporting (pivot tables, charts, analysis, formulas, etc…)
• 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

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.

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, 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 and cover letter.

We look forward to hearing from you!