Join the GMED team today and work on the frontier of Medical Device Innovation!
Location(s): North Bethesda, MD
Contract Type: Full-Time
Fields: Medical Device, In Vitro Diagnostics – Healthcare
The European Union recently published a new set of Regulations for the medical device sector. These new Regulations reinforce the pre-requisites and on-going pathway to qualify and maintain competences for the technical personnel involved in the evaluation of Medical Device technologies.
The Qualification Coordinator will safeguard and act as the timekeeper of all qualification projects to ensure successful completion.
Under the supervision of the Talent Acquisition and Qualification Manager, he/she applies a project management approach and methodology to define, launch and monitor the evolution and completion of project milestones for every qualification file. Through the use of dedicated tools, he/she will plan, implement, record and maintain, the qualification pathway to meet the company needs and for each profiles, ensure that they align with our internal processes, the Regulations as well as the company’s evolutions.
He/she will be dealing with a variety of technical profiles whose background can vary greatly depending on their degrees and industry experience, to optimize the qualification practices, while improving the use of dedicated tools.
This position will report directly to the Talent Acquisition and Qualification Manager.
• Organizes the different steps of the qualification pathway for each technical personnel;
• Records, maintains and updates all qualification files for GMED NA employees;
• Maintains and optimizes the qualification tracking system through the development and use of new tools;
• Defines a systemic filing procedure to be implemented and reinforced within the Talent Acquisition and Qualification Department;
• Handles the scheduling and planning of all department activities relating to the qualification pathway, including qualification meetings, conferences, working groups;
• Suggests and improves the qualification tasks workflow to increase efficiency;
• Acts as a Liaison with other departments, interact with Department Unit Managers and Technical Experts located in our Headquarters in Paris;
• Handles highly confidential and non-routine information relating to candidate files;
• Explains regulations and its application within the qualification process when necessary;
• Acts as Project Manager for the qualification projects (exceptional but also routine projects), managing from start to finish the follow up of all key milestones, within defined and scrutinized timelines, to guarantee successful completion;
• Creates and coordinates presentations relating to the Talent Acquisition and Qualification Department processes and ensure dissemination of information within the organization;
• Assesses and implements digital qualification tools as needed;
• Types and designs accurate and concise briefs, communication memos to include charts, tables, graphs;
• Performs other duties and responsibilities as required or requested or delegated.
Who You Are
Required Education and Experience
• Bachelor’s degree or equivalent in related fields such as biomedical or medical engineering, biotechnology, public health, pharmacy, quality assurance (QA) and regulatory affairs or other relevant fields.
• 3 years of experience in project coordination.
• French proficiency.
• Working in a fast-paced environment.
• Professional experience working with Medical Devices or/and Certification processes within a healthcare agency.
• Experience creating, working and optimizing the use of multiple entry databases.
• Project Management skills.
• Working with MS Pack Office (Word, Excel, Power Point & Outlook);
• Highly proficient in the use of Microsoft Excel (creating dedicated tools, detailed reporting, consolidating and extracting data for analysis of trend, using accurately multiple Excel functions);
• Comfortable with the use of digital tools that require customization and implementation;
• Thorough and concise;
• Meticulous and detail-oriented;
• Exceptional organizational skills;
• Ability to follow direction, manage multiple projects and meet challenging deadlines;
• Self-starter who works well independently but also in various group settings;
• Team player, reliable and focused on core missions;
• Impartial and discreet when managing confidential information;
• Ability to create an environment that promotes trust when interacting with the personnel throughout the qualification process.
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 an important part 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 backgrounds and culture.
• Commitment to Clients and Patients’ safety
• Team Work
What We Offer
We offer an 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 program providing our employees with great work-life balance. We offer growth opportunities within the organization. There are a lot of opportunities and employees can 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 a copy your transcripts together with your resume and your application letter.
We look forward to hearing from you!