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Medical Device Lead Auditor

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

The European Union recently published a new set of Regulations for the medical device sector. These new Regulations reinforce the pre-requisites and on-going pathway to perform audits at Medical Device manufacturers. As Lead auditor, you act as one of GMED’s top representative, managing an assigned portfolio of medical device customers for audits and reviews. The tasks that fall under your responsibility include:

• The organization of travel plan(s),
• The conduct of audit visit(s) and assessment(s),
• The issuance of detailed reporting(s) within defined timelines and according to company procedures,
• The management of correspondence between the customer(s) and the Operational team units at GMED North America, including the Certification Project Manager Unit, the Planning & Resource Unit and the Financial Unit.

You embody GMED North America’ values and commitment, both internally and externally, through your communication and provide training(s) when required, based on your qualification(s), certification(s) and, working experience(s).
You lead teams of auditors, coach new and/or junior team member(s) of the Certification team when needed and, follow the training(s)/qualification plan(s) defined by our Talent Acquisition and Qualification Unit to comply, maintain and/or increase your qualification(s).

This position will report directly to the Certification Department Director.

Essential Functions

Upon completing successfully, your qualification pathway at GMED, you will, as Lead Auditor or Auditor (so part of an audit team), conduct professional certification audit(s) for the Medical Device sector. These can occur off-site or/and on-site, at the client’s premises, and must be performed in accordance with GMED’s audit procedure(s), process(es), policy(-ies) , with the defined capacity objective(s), and according to:

• Quality Management Systems according to ISO Standard(s):

  • ISO 9001:2015
  • ISO 13485:2016
  • ISO 13485:2016 under the requirements of the Medical Device Single Audit Program (MDSAP)

• CE Marking certification under the applicable European Medical Device Directive(s) & Regulation(s):

  • Medical Device Directive 93/42/EEC (MDD)
  • Active Medical Device Implantable 90/385/EEC (AIMD)
  • In Vitro Diagnostic Devices 98/79/EC (IVDD)
  • EU MDR 2017/745
  • EU IVDR 2017/746

As Lead Auditor, you will be responsible for the:

• Control of the quality of the service(s) performed and contribute to the quality assurance of service(s) delivered:

  • by respecting the quality procedure(s) and the directive(s) of managers, especially regarding the conduct of assessment service(s),
  • by identifying the need(s) of procedure(s) update(s),
  • by ensuring that the service is performed in compliance with the specifications or/and with the certification reference(s) agreed upon (methodology, cost(s), deadline(s) etc.),
  • by writing report(s)/memo(s), in a clear, concise and impartial way, indicating the level(s) of conformity to be reached and separating the activities that fall under different certification system(s) (regulatory and voluntary),
  • by providing support in the handling of anomalies, complaint(s), and claim(s), proposing corrective action(s) to ensure those will not be repeated and supporting a continuous improvement(s) approach of the organization’ process(es).

• Ensure the best level of service(s) is delivered and in compliance with referenced rule(s) & standard(s);
• Ensure the level of scientific and technical skill(s) necessary for the performance of your task(s);
• Ensure the achievement of the personal objective(s) defined by your line management and contributing to achieve the collective quantitative objective(s);
• Contribute to the team spirit;
• Contribute to the business development and communication effort(s), and promote the 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, e.g. medicine, pharmacy, engineering or other relevant sciences;
• 4 years of professional experience in healthcare, dealing with products or related activities, such as manufacturing, auditing or research and development (R&D); of which 2 years shall be in the area of quality management.

Competencies

• Proficient in Word, Excel, Power Point & Outlook.
• Proficient in English.
• Leadership and Decision making.
• Excellent verbal and written communication / presentation skill(s).
• Critical reasoning and ability to draw up demonstrative record(s) and report(s)
• Thorough and concise.
• Meticulous and detail oriented.
• Exceptional organizational skills.
• Ability to follow direction, manage multiple projects and meet challenging deadlines.
• Self-starter who works well independently but also in various group settings.
• Team player, reliable and focused on core missions.
• Impartial and discreet when managing confidential information.
• Ability to create an environment that promotes trust when interacting with the team member(s) throughout the project(s).

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 backgrounds and culture. 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.

We look forward to hearing from you!

Apply Today

 

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

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clientsWe're Hiring!

Due to our rapid growth in North America, we're seeking Lead Auditors.