Lead Auditor

Medical Device QA Auditor

Join the GMED team today and work on the frontier of Medical Device Innovation!

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

Who We Are

GMED North America is the US subsidiary of GMED, a leading Certification Organization, a distinguished Notified Body (CE0459) Authorized to act under European Regulation (EU) 2017/745 on medical devices, European Directives 90/385/EEC, 93/42/EEC, 98/79/EC and Regulation n 722/2012 on products utilizing tissues of animal origin, GMED certifies a vast range of medical devices and in vitro diagnostic medical devices. 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 the cornerstone of this process because their work directly influences GMED North America's reputation.

Aside from our expertise with due diligence, we pride ourselves in our diverse workforces, with employees from different parts of the world.

Our Values:

• Commitment to Clients and Patients' safety
• Expertise
• Reliability
• Team Work

What We Offer

At GMED North America, our primary goal is to attract and retain exceptional talent who are not only subject matter experts, but also passionate about upholding the integrity and excellence of our services. We recognize that our success is driven by the expertise and commitment of our team, and we are focused on creating an environment where top professionals can thrive.

GMED North America offers a full and competitive benefits package including 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, and a 401K retirement program. We promote work-life balance through the option to telework, flexible working arrangements, generous time off program, paid holidays, paid bereavement leave, paid parental leave, commuter benefits program for public transportation, and internet stipend.

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.

Thank you for your interest in GMED North America.

We look forward to hearing from you!