Join the GMED team today and work on the frontier of Medical Device Innovation!
Location(s): Hybrid (on-site three days per week, Rockville, MD office)
Reports to: Certification Division Director
Division: Certification
Position Classification: Exempt, Full-Time
Fields: Medical Devices, In-Vitro Diagnostics - Healthcare
Ref: MD-GMED-129-03-01
Job Description
- Manage the processing team (Cert Processing coordinators) and oversee their day-to-day work.
- Manage the Time-To-Decision as the core department deliverable.
- Leading added value, efficiency and quality added initiatives aimed at business and QMS processes as well as increasing process predictability.
- Managing the administrative/legal changes of client base in coordination with the compliance division.
- Manage certificate validation activities in coordination with HQ.
Essential Functions
Department management:
- Responsible for hiring, attendance, training, qualification, and development, reviewing performance, termination, and administering corrective action for staff.
- Determine the capacity metrics for the department and monitor the need for resources and tools.
- Determine standards of performance as a basis to review progress of department personnel.
- Communicate areas of accountability and performance expected of department personnel.
- Collect, analyze, and report Department KPIs on a continuous basis with frequent reporting to division and HQ as needed.
- Help in the creation of division roadmap projects and manage, deploy, and report projects assigned to the department.
Processing tasks:
- Manage timeliness and quality of processes related to pre-service, post service activities (contract, packages, reports, committees, and decisions).
- Tracks metrics and ensure processing timelines are met. Solve delays and issues for the team.
- Develop and promote the implementation of best practices within the team.
- Identify, develop, and deploy process enhancements.
- Increase the effectiveness of the operational processes, tactically and strategically, by automating tasks whenever possible. Anticipation of service evolution and smooth adaptation to changes.
- Manage client requests and client satisfaction in coordination with the CPM and CSU.
Project Management:
- Implements smooth and efficient workflows in all areas of the service processing team, and of the certification division.
- Identify and translate into technical specifications the business needs for system improvements.
- Work with other departments to ensure change management and updating of processes where applicable.
- Maintains a favorable working relationship with all external resources and internal employees.
Who You Are
Job Specific Competencies:
- Solid data analysis and KPI skills with advanced computer skills
- Strong problem Solving/Root Cause Analysis skills.
- Customer/Client Focus
- Advanced organizational skills
- Intermediate management skills
- Communication Proficiency and must demonstrate teamwork efforts.
- Intermediate knowledge of legal entity structures, budgets, and profitability
Required Education and Experience:
- Relevant training certifications in industry topics helpful.
- Bachelor of Science in management/quality. Master’s degree preferred.
- ISO 17021, ISO 9001
- Full mastery of lean management methodology/advanced supply chain skills
- Language Preferred: English and French a plus
- Background in USA entity laws a plus
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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