Post-Market Surveillance & Quality Auditor (ISO 13485)

Vision RT Ltd.

Nashua (NH)

On-site

USD 60,000 - 90,000

Full time

14 days+

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Job summary

Vision RT is a fast-growing MedTech company transforming radiation therapy for cancer patients by helping make it more accurate, effective, and comfortable. The company is the inventor of Surface Guided Radiation Therapy (SGRT) and a market leader in the field.

The Post-Market Surveillance team is backfilling a position after a career development. The role focuses on investigating support tickets, root-cause analysis, and regulatory report writing, with occasional travel to the UK and

Qualifications

Strong administration skills and attention to detail.
Analytical and problem-solving skills.
Able to work independently and collaboratively, and prioritise tasks.
Proficient in Microsoft Office.
Fluent in written and spoken English.

Responsibilities

Assist in reviewing and classifying complaints per regulations and procedures to determine reportability.
Under supervision, investigate complaints with internal and external stakeholders and determine root causes.
Collaborate with Risk Management and internal teams for initial risk assessments.
Support audits by notified bodies and third parties.
Work with Production, R&D and Service and other teams within Quality & Regulatory Compliance.
After training, act as an internal auditor to ISO 13485, MDSAP and EU MDR.
Undertake other duties as reasonably required.
This role requires occasional UK and international travel.