Reports to: Unit Manager

Division: Certification

Position Classification: Exempt, Full-Time

Fields: Medical Devices, In-Vitro Diagnostics - Healthcare

Location(s): Rockville, MD or Remote (Home office)

Job Description

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.

Essential Functions

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:

• 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

Manage a portfolio of assigned clients based on geographic location and a match of qualifications and client contract requirements. Client management includes contacting them to schedule the visit, planning the assessment, making appropriate travel plans, conducting assessments, completing reports, and managing results.

Participate in professional development and training opportunities to achieve necessary certifications and statuses

Therapeutic Area of interest

• Oncology
• Ophthalmology
• Rehabilitation, Hospital Equipment
• Gynecology, Obstetric, Contraception
• Orthopedic
• Neurology
• Gastroenterology
• ENT
• Nephrology
• Reconstructive Implant
• Anesthesia
• Infusion/Drug delivery
• Dental
• Wound Treatment

Support Field

• Sterilization (ETO, IRRADIATION, STEAM, ATYPICAL)
• Bio-active coating
• Medicinal Substance

Who You Are

Required Education and Experience:

• 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)

Job-specific Competencies:

• 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