Quality Specialist

Job Details

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

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

Reports to: Quality Manager

Division: Compliance Division - Quality Department

Position Classification: Exempt, Full Time

Fields: Medical Device, In Vitro Diagnostics - Healthcare

Ref: MD-GMED-130-03-08

Job Description

This is an exciting opportunity to join GMED NA and work as a Quality Specialist.

As a Quality Specialist, you will work within the framework of the objectives set up by your manager, the GMED certification quality policy set by management, and in accordance with best practice
Essential Functions

• Ensure KPIs suitability to guarantee that the quality of services comply with our local procedures, our group QMS, applicable standards and regulations (ISO 17021-1, specific IAF documents, European regulations, etc.),
• Participate in updating or establishing quality indicators and activity indicators defined by management, and contribute to their analysis,
• Ensure appropriate adherence to procedures and appropriate stakeholder involvement.
• Participate in or lead quality projects based on SMART goals of the department.
• Follow-up on anomalies status (deviation) and complaints
• Concession: train, support GMED NA team members if they have questions on concessions and ensure compliance for quick acceptability by HQ,
• Promotion of a quality driven environment:
  • Ensure that all staff understand and adopt the provisions of the quality system,
  • Write, participate, or support in the writing of document control, procedures, and forms,
  • Support learning and development sessions for employees and HR in improving the onboarding of new employees.
  • Ensures that the documentation system is kept up to date with changes in standards, regulations, and operations, by defining necessary changes or coordinating updates resulting from the work of other employees,
  • Support the implementation of changes for support divisions such as Operation, Business development (training, support, monitoring)
• Monitor (monthly) updates of Quality System received from GMED SAS (review, log, communication)
• Assist when needed in accreditation bodies' audits, competent authorities' inspections, internal audits.
• Ensure that quality provisions of GMED NA are:
  • Described and documented,
  • Distributed to, or accessible by, the personnel concerned,
  • Understood and applied,
  • Regularly reviewed, and revised, if necessary, to ensure their effectiveness
  • Ensure the coherence of all defined provisions,
• Archive obsolete Quality documents, quality records.

Who You Are

Required Education and Experience:

• Bachelor of Science in Quality Assurance, Quality Management, Engineering, Sciences, Statistics or Data Analytics.
• A comprehensive understanding of QMS requirements as applied to medical devices including applicable regulations and standards (such as ISO 13485, MDD/AIMD/IVDD, MDR/IVDR, MDSAP requirements).
• Minimum of two years of experience in a quality role in a QMS controlled environment (Pharmaceutical, Medical Devices, In-Vitro Diagnostic Devices, Laboratories, ...)
• Fluency in French is a strong plus

Job-specific Competencies:

• Excellent written and verbal communication (English proficiency required, French is a strong plus)
• Strong personal and data presentation skills.
• Microsoft office & remote meeting platforms essential.
• Ability to foster collaboration across diverse divisions and departments.
• Excellent attention to detail.
• Ability to work independently.
• Ability to meet deadlines.
• Problem solving / critical thinking.

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
• Teamwork

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 and cover letter.

We look forward to hearing from you!

#LI-Hybrid

 GMED NA

 04/18/2024

 Rockville,MD