- Quality Management Systems according to ISO Standards ISO 9001:2015 and ISO13485:2016,
- 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
- Due to strict regulatory requirements, only candidates with Bachelor's degrees in computer and software technology, biology, chemistry, biochemistry, electrical/electronic/mechanical or bioengineering, human physiology, medicine, physics, or biophysics, will be considered for this role.
- A 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 the area of quality management (experience working in an organization governed by regulations and standards)
- Oncology
- Ophthalmology
- Rehabilitation, Hospital Equipment
- Gynecology, Obstetric, Contraception
- Orthopedic
- Neurology
- Gastroenterology
- ENT
- Nephrology
- Reconstructive Implant
- Anesthesia
- Infusion/Drug delivery
- Dental
- Wound Treatment
- Sterilization (ETO, IRRADIATION, STEAM, ATYPICAL)
- Bio-active coating
- Medicinal Substance
- Impartiality
- Confidentiality
- Ability to function independently and in a team environment
- Organizational skills & time management
- Attention to details
- Strong oral and written communication skills
- Critical reasoning
- Decision making
- English language skills
- Leadership skills
- Ability to draw up demonstrative records and reports
- Reliability and accountability
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Lead Auditor - Rockville, United States - GMED NA
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Description
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.
GMED North America is hiring a Medical Device QA Auditor with prior industry experience to join our US team. This is a home-based role with travel to client sites.
Utilizing their past experience in engineering, design, or quality control of medical devices, combined with rigorous GMED training, our QA Auditors conduct ISO 13485/MDSAP audits and CE Marking activities for clients to ensure products meet international standards and are go-to-market ready.
The ideal candidate will need hands-on technical experience with medical devices in the following categories: active devices, non-active device, plastics, and metals.
Medical Device Auditor Responsibilities
Deliver GMED NA's third-party audit services to assigned clients in accordance with all GMED, scheme and regulatory requirements to assure timely, cost effective service delivery that assures satisfaction of our customer needs. Analyze quality systems and assess:
Participate in professional development and training opportunities to achieve necessary certifications and statuses
Required Education/Qualifications
We offer an excellent benefits package including a group-sponsored health, dental and vision coverage, short-term and long-term disability, 401k plan, company paid life insurance, paid holidays and time off program, Compensatory Time Off providing our employees with great work-life balance.
GMED North America is an Equal Employment Opportunity Employer, committed to a diverse, inclusive, and healthy work environment with a unique culture.
Employment Type
Full-time #LI-Remote