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Medical Devices Quality Assurance Specialist
hace 2 meses
Job Title: Medical Devices Auditor
Company: BSI Companies
Location: Field-based, with 70-75% travel required within EMEA
About the RoleWe are seeking a talented Medical Devices Auditor to join our team. As a Medical Devices Auditor, you will be responsible for assessing quality management systems to ensure patient safety and regulatory compliance. You will work with various clients across EMEA, conducting audits on-site, remotely, or hybrid, and writing detailed reports.
Responsibilities- Conduct audits on-site, remotely, or hybrid, working alone or as part of a team.
- Write detailed reports and liaise with the planning team and delivery manager to manage client relationships and audit schedules.
- Complete other administrative tasks as required.
To be successful in this role, you will need:
- A minimum of 4 years of hands-on experience in one or more of the following areas:
- Research and development.
- Design or design development.
- Servicing, maintenance, and testing.
- Manufacturing or production experience.
- Active devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners.
- IVD (in vitro diagnostics) instrumentation and/or reagents.
- Active Implantable Medical Devices: Cochlear Implants, MEMS systems, Implantable infusion pumps, including Software as a Medical Device.
- Orthopaedics - spinal implants, bone/dental cements, cartilage, and soft tissue repair.
- Wound and skin care - dressings, foams, gels.
- Biology or Microbiology.
- Chemistry or Biochemistry.
- Computer and Software Technology.
- Electrical, Electronic, Mechanical, or Bioengineering.
- Human Physiology.
- Medicine.
- Pharmacy.
- Physics or Biophysics.
As a Medical Devices Auditor at BSI Companies, you will have the opportunity to work with a global partner for 86,000 companies and organizations in over 193 countries. You will be part of a dynamic team that is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are passionate about quality management systems and patient safety, and have the skills and experience required for this role, we encourage you to apply.
