envelope  Contact us

phone1-301-495-0477

Operation Director (For Medical Device Certification)

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

Location(s): North Bethesda, MD
Contract Type: Perm Full-Time
Fields: Medical Device, In Vitro Diagnostics – Healthcare

Interested in working with a team of technical experts in the Medical Device Industry to gain experience and advance in your career with GMED North America? If Yes, we would love to hear from you.

Job description

Summary

The Operations Director main mission is to oversee and direct daily execution of all aspects of operations activities such as managing and optimizing services’ efficiency & planning and, ensuring the achievement of operations’ objectives through the control of the administrative workflow and through the available digital solutions tools and strategy to back up all different requirements. This position will report directly to the CEO.

Essential Functions

  • Oversee the implementation and reliability of all operations’ activities following the requirements, procedures and defined timelines and budgets;
  • Ensure the management and optimization of the operations’ activities based on the regulatory needs, quality needs and company objectives;
  • Ensure the management of the Department within the defined objectives and company’s values;
  • Participate to procedures maintenance, development and improvement in coordination with HQ and all involved North American departments;
  • Contribute to the definition of production quantitative (global and individual) objectives and implement the necessary actions to reach these objectives;
  • Guarantee operations’ efficiency, operations’ cost management and implementation;
  • Consistently enforce Company policies, procedures and values;
  • Ensure the sustainability, business continuity and development of the activities;
  • Facilitate and participate to all third party or HQ audits and inspections;
  • Ensure client satisfaction;
  • Manage outsourcing of services with auditors, evaluators and external experts, define the pricing/buying conditions and the processing of operations’ costs in accordance with profitability goals;
  • Contribute to the development external and internal production resources and to the optimization of their qualification;
  • Pilot and contribute to the waste elimination, automation and industrialization of the services;
  • Monitor, analyze and report on a consistent basis the production volumes, services costs, capacities, ROIs, resources needs and projections (days, services, revenue, cost);
  • Work with Department leads on: Strategy building, Budget building, Service creation, Client landing, Qualification, Client retention and client acquisition;
  • Is responsible for hiring, terminating, training and developing, reviewing performance and administering corrective action for leading managers under his/ her supervision. Communicate areas of accountability and performance expected of personnel assigned based on the given frame and the approved budget;
  • Communicate areas of accountability and performance expected of personnel assigned;
  • Determine standards of performance as a basis to review progress of personnel assigned;
  • Perform other duties and responsibilities as required or requested or delegated.

Who You Are

Required Education and Experience

  1. Bachelor’s degree (BS/BA) in business administration, industrial engineering or related field.
  2. Knowledge of industrial engineering, human resources laws and regulations, and employee relations skills.
  3. 5 to 10 years Operations management in the domain of complexes services.
  4. 3 to 5 years with demonstrated management experience.

Preferred Education and Experience

  1. Master’s degree in a business, financial or related field.
  2. Knowledge of the medical device domain preferred.

Competencies

  1. Business Acumen.
  2. Change Agent.
  3. Collaboration Skills.
  4. Communication Proficiency.
  5. Decision Making.
  6. Initiative.
  7. Leadership.
  8. Problem Solving/Analysis.
  9. Results Driven.

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 work forces, 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 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 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 a copy your transcripts together with your resume and your application letter.

Must be able to work without a need for Visa sponsorship

We look forward to hearing from you!

Send your application to hr@lne-gmed.com

Apply Today

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

Get a quote proposal

   1-301-495-0477

clientsWe're Hiring!

Due to our rapid growth in North America, we're seeking Lead Auditors, and Resources Qualification Manager For Medical Devices Certification