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
Join the GMED NA team today and work on the frontier of Medical Device Innovation!
As Lead auditor, you will be GMED's ambassador, you will need to manage assigned customer's audits: organize travel plans, conduct audit visits and assessments, issue reporting in a timely manner, manage correspondence with the customer and G-MED operations (including Certification Project Manager, Planning and Financial teams).
You will embody GMED NA's values and commitment in both internal and external communication to organizations (client communication, events, conferences, etc.) and provide training when required, based on certification/experience and business needs.
You will lead audit team(s), coach new or inexperienced team members if needed, and comply with any training/qualification plans defined by the Talent Acquisition and Qualification unit to maintain and/or increase qualification(s).
You will report directly to the Certification Department Director.
Upon successful qualification, you will conduct professional certification audits (on and off-site) as Lead Auditor or Auditor (as part of a team) in accordance with GMED procedures, processes, policies and objective capacity for:
- Quality Management Systems according to ISO Standards ISO 9001:2015 and ISO 13485:2016,
- CE Marking certification under the applicable European Directives & Regulations:
- Medical Devices 93/42/EEC (MDD),
- Active Medical Device Implantable 90/385/EEC (AIMD)
- In Vitro Diagnostics devices 98/79/EC (IVDD)
- EU MDR 2017/745
- EU IVDR 2017/746
- Quality Management Systems under the requirements of the Medical Device Single Audit Program MDSAP,
As Lead Auditor, you will be responsible for:
- Controlling the quality of services that they realize and contributes to the quality assurance of services offered:
- by respecting the quality procedures and the directives coming from their managers, especially regarding the conduct of assessment services,
- by identifying procedure update needs,
- by controlling that the service is performed in compliance with the specifications or with the certification references agreed upon (method, cost, deadlines),
- by writing reports/memo, in a clear and unbiased way, showing the levels of conformity to be
- reached and separating the activities that fall under different certification systems (regulatory and voluntary),
- by providing their help for the handling of anomalies, complaints, and claims and
- by proposing corrective actions that would avoid them to happen again.
- Ensuring the best level of service in compliance with reference rules and standards;
- Ensuring the level of scientific and technical skills necessary for the performance of your tasks;
- Ensuring the achievement of the personal objectives defined by your line management and contributing to reach the collective quantitative objectives;
- Contributing to team spirit;
- Contributing to business development and image/branding of the company.
Who You Are
Required Education and Experience:
- Successful completion of a university or a technical college degree or equivalent qualification in relevant studies, such as medicine, pharmacy, engineering or other relevant sciences;
- 4 years of professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research;
- Of which 2 years shall be in the area of quality management.
- Ability to function independently and in a team environment
- Attention to details
- Strong oral and written communication skills
- Critical reasoning
- Decision making
- English language skills
- Leadership skills
- Organizational skills & time management
- Ability to draw up demonstrative records and reports
- Reliability and accountability
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 parts of the World.
- Commitment to Clients and Patients’ safety
- Team Work
What We Offer
We offer an excellent benefits package including group-sponsored health, dental and vision coverage, short-term and long-term disability, a company-matched 401k plan, company-paid life insurance, paid holidays and time off program, Compensatory Time Off 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 of your transcripts together with your resume and your cover letter.
We look forward to hearing from you!