Certification Manager

2 weeks ago

Rockville, United States GMED NA Full time
Join the GMED team today and work on the frontier of Medical Device Innovation

Reports to: Certification Division Director

Division: Certification

Position Classification: Exempt, Full-Time

Fields: Medical Devices, In-Vitro Diagnostics - Healthcare

Location(s): Hybrid (on-site three days per week, Rockville, MD office)
Job Description

The Certification Manager leads a team of Certification Project Managers and Lead Auditors, while ensuring adherence to company policies and processes. This role is responsible for the growth of the department's resources and client base. The Certification Manager acts as an interface between internal and external customers and the certification staff to ensure effective delivery of the certification process.
Essential Functions

Management:
  • Deploy the AO/CAB department vision, mission, and annual goals (see annex 1)
  • Supervise subordinate managers and team members.
  • Engage in intra and inter division management meetings with inputs and outputs.
  • Define the long-term development and structure of the department.
  • Interview, hire, train, and develop staff capacity and career paths.
  • Foster positive working relationships with external and internal employees.
  • Administer the budget for the business unit.
Service Delivery & Productivity
  • Ensure the department timely delivery of services.
  • Ensure the department forecasting of client needs and communicate with other departments/divisions.
  • Ensure AO/ISO services are streamlined, competitive and foster growth.
  • Track and report individual and team capacity, ensuring adherence to budget and timelines.
  • Analyzes productivity and efficiency, and recommend actions for improvement, and coordinate with management to establish policies and procedures.
Development and Branding:
  • Provide support to the Business Development and Marketing team to increase market share.
  • Ensure the department's technical capabilities answer to the needs of the client base.
  • Promote the company's activities and reputation.
  • Contribute to the development of internal or external training programs.
  • Foster innovative projects to increase the visibility of our expertise and values.
Customer Focus:
  • Enhance the company's customer service reputation.
  • Ensure responsiveness, clarity, and visibility in customer communication.
  • Analyze and present trends to deploy global solutions.
  • Secure client retention, satisfaction, and service portfolio.
Monitoring and Reporting:
  • Monitor and report individual and department KPIs.
  • Monitor and report client base status.
  • Monitor and report department road map implementation status.
Quality:
  • Incorporate company standards of excellence.
  • Ensure department adherence to company quality processes, procedures, and best practices.
  • Ensure deliverables, communication, and projects adhere to the highest quality standards.
Regulatory:
  • Ensure the department stays current on regulatory aspects.
  • Participate in producing regulatory content.
  • Represent the department during audits and inspections.
  • Ensure the department's adherence to regulatory requirements.
Technical:
  • Continuously evaluate, analyze, and report on technological strengths and improvement points.
  • Assign client portfolios in line with individual core competencies.
  • Assess individuals based on the core competencies of the department.
  • Responsible for the qualification and extension/maintenance of qualification of the department's resources.
Other duties:
  • Performs assigned duties from Certification Director.
Who You Are

Required Education and Experience:
  • Current Certification Project manager qualifications
  • Bachelor's degree in business, engineering, or a related field.
  • Strong leadership, interpersonal, communication, and problem-solving skills.
  • Experience in a certification, regulatory, or medical device industry.
  • Proficient in Microsoft Office suite and project management tools.
  • Certification in project management, quality management, or related fields.
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

GMED North America is an Equal Employment Opportunity Employer, committed to a diverse, inclusive, and healthy work environment with a unique culture. GMED North America recruits, employs, trains, compensates, and promotes regardless of race, religion, sex, national origin, ethnicity, age, disability, pregnancy, political affiliation, sexual orientation, gender identity, color, marital status, veteran status, medical condition, and all the other characteristics that make us unique.
What We Offer

At GMED North America, our primary goal is to attract and retain exceptional talent who are not only subject matter experts, but also passionate about upholding the integrity and excellence of our services. We recognize that our success is driven by the expertise and commitment of our team, and we are focused on creating an environment where top professionals can thrive.

GMED North America offers a full and competitive benefits package including group-sponsored health, dental, and vision coverage, flexible spending accounts, short-term and long-term disability, company-paid life insurance, competitive base salary, annual bonus based on company performance, and a 401K retirement program. We promote work-life balance through the option to telework, flexible working arrangements, generous time off program, paid holidays, paid bereavement leave, paid parental leave, commuter benefits program for public transportation, and internet stipend.

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.

Thank you for your interest in GMED North America.

We look forward to hearing from you

#LI-Hybrid

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