General information
Location
Solihull
Type of contract
Permanent
Full Time
Occupational field
Auditing & Consulting
Job-ID
12675
Job Summary
TUV Rheinland UK is looking for a Lead Auditor, responsible for planning and conducting medical device audits in compliance with EU and UK Regulations/Legislation.
Job Description
* Plans, prepares and carries out audits in compliance with EU MDR, EU IVDR, UK MDR, MDSAP, and ISO 13485.
* Coordinates the schedule and audit plan with the customer and, if necessary, with the auditor team.
* Collects and analyses data to detect deficient controls, duplicated effort, fraud or noncompliance with laws, regulations, and management policies.
* Might lead the audit in the function of the lead auditor.
* Records strengths, deviations, recommendations and evidence viewed.
* Creates audit documentation and audit reports.
* Prepares and explains audit findings and recommends solutions to auditee.
* And other duties as assigned.
Essential Requirements:
* 2 years' experience as medical device auditor.
* 2 years' experience in Design, Manufacturing, or Testing of Medical Devices.
* Ideally registered IRCA auditor or equivalent recognition with a recognised body.
* Knowledge of UK MDR 2002.
* Knowledge of ISO 13485.
* Knowledge of EU MDD 93/42/EC, EU MDR 2017/745.
* Significant UK travel with limited international travel.
* Full UK Driving Licence.
Benefits
Positive working atmosphere.
Additional information
Location
Friars Gate (Third Floor) 1011 Stratford Road Shirley, Solihull
B90 4BN Solihull
Company
As an international services group, we want to create a working environment in which all our employees feel secure and comfortable - an environment in which they enjoy giving their best with commitment. The key to this lies in an open, respectful cooperation across all countries, cultures and lifestyles. After all, around 20,000 employees at 500 locations around the globe provide more than 2,500 services. The results of their work can be seen everywhere: in tested elevators or rides, on certified toys or technical equipment, in our consultations or training sessions. No matter where - our international teams have been setting standards in terms of safety, quality and efficiency for many years.
We value diversity - and take on responsibility
Our specialists appreciate this versatile portfolio, the exciting tasks and the value of their work for people, the environment and technology. And we value our specialists for their know-how and commitment, but also for their different personalities and careers. Combined with the professionalism and sense of responsibility of each individual, we create a culture of openness, growth and collegiality. We want to further strengthen this culture and consistently promote respect in our dealings with one another. Not only do we say that, we live that. We have committed ourselves to acting in accordance with the principles of the UN Global Compact initiative, to fighting corruption and to working for human rights, labour standards and environmental protection in our daily work. We are active in numerous networks and projects that stand for diversity and equality. In addition, we have developed a broad range of products and services that help to reconcile the professional and private worlds so that our employees can work in a healthy, motivated and optimal environment.
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