Lead Auditor

🔥 1 hour ago

🦀 Maryland – Remote

🦀 Maryland – Remote

⏰ Full Time

🟠 Senior

🔎 Auditor

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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GMED

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1994

🏥 Healthcare

📋 Compliance

🤝 B2B

Healthcare • Compliance • B2B

GMED is an international notified body and certification body specializing in medical devices. GMED assesses conformity of medical devices and quality management systems (QMS) to enable manufacturers to place products on global markets, offering CE marking, QMS certification, MDSAP program support, device testing, and training. With over 30 years of experience and teams dedicated to Europe, Asia and North America, GMED covers a range of device types including implantable, custom-made, electromedical and in vitro diagnostic devices, and operates as part of the LNE group.

📋 Description

• Conduct GMED North America’s third-party audit services for assigned clients • Analyze quality systems according to ISO standards ISO 9001:2015 and ISO 13485:2016 • Assess CE Marking certification under applicable European Directives and Regulations • Assess quality management systems under MDSAP requirements • Manage a portfolio of assigned clients based on geographic location, qualifications, and contract requirements • Contact clients to schedule visits • Plan assessments and make travel arrangements • Conduct client-site assessments • Complete audit reports and manage results • Participate in professional development and training to achieve necessary certifications and statuses • Ensure timely, cost-effective service delivery and customer satisfaction

🎯 Requirements

• Bachelor’s degree in computer and software technology, biology, chemistry, biochemistry, electrical/electronic/mechanical or bioengineering, human physiology, medicine, physics, or biophysics • Minimum of four years of full-time hands-on (R&D, manufacturing, testing and/or auditing) work experience in the field of medical devices or related sectors • At least two years in quality management, working in an organization governed by regulations and standards • Hands-on technical experience with active devices, non-active devices, plastics, and metals • Knowledge of ISO 9001:2015 and ISO 13485:2016 • Knowledge of CE Marking certification and applicable European Directives and Regulations • Knowledge of MDSAP requirements • English language skills • Ability to draw up demonstrative records and reports • Impartiality • Confidentiality • Ability to function independently and in a team environment • Organizational skills and time management • Attention to detail • Strong oral and written communication skills • Critical reasoning • Decision making • Leadership skills • Reliability and accountability

🏖️ Benefits

• 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 • 401K retirement program • Option to telework • Flexible working arrangements • Generous time off program • Paid holidays • Paid bereavement leave • Paid parental leave • Commuter benefits program for public transportation • Internet stipend • Growth opportunities within the organization • Opportunities to apply and move into different roles within the company