MICROBIOLOGY PRODUCT SPECIALIST/AUDITOR - STERILITY - GERMANY
Posted on Apr 13, 2019 by Bosch Global Associates Ltd
JOB TITLE: Product Specialist/Microbiologist/Medical Devices Expert.
REPORTS TO: Microbiology Medical Device Manager.
SALARY: 60-80k Eur.
The job holder is a medical device expert responsible for managing activities in the assigned specialist technological area of sterilization and microbiology, ensuring the utilisation of appropriate technical expertise for reviewing medical devices technical documentation and quality systems and attending assessments as technical expert or providing expert briefing.
The job holder must be competent to review critical data (including sterilization validation), routinely at the cutting edge of technology where no product standards or device experience exists.
To manage between 50 and 100 (depending on complexity and risks) allocated clients/Projects, with responsibility to deliver an agreed revenue.
The job holder is expected to maintain a position of leadership in the assigned industry sector, recognised and acknowledged by external agencies
(Medicines and Healthcare Regulatory Agency, Food and Drug Administration, USA, Trade Associations) as an expert.
The job holder prepares contracts that specify the appropriate technical expertise required for quality systems assessments, attending assessments as technical expert or providing expert briefing.
The job holder is also be responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements.
The job holder is an expert reference point both internally and externally, familiar with regulatory and technological developments, able to brief staff and industry as appropriate.
The job holder will conduct comprehensive in-depth medical device reviews (including sterilization validation).
The medical device review activity is conducted in an environment of high potential risk, the job holder must be competent to analyse risks against benefits, in an environment where a favourable decision from the notified body will potentially lead to very large commercial benefits for the device manufacturer.
The job holder determines when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective.
On occasions the job holder will need to make decisions and critical judgement on site under pressure from the client and the clients experts (internal and external).
The job holder is one of several medical technology managers in the medical devices group.
Each medical technology manager is responsible for a defined area of medical device technology.
The medical devices technology managers must be sufficiently qualified and experienced that they are competent to review cutting edge technology with customers.
KNOWLEDGE SKILLS & EXPERIENCE:
The position requires a thorough understanding of the allocated technological area. The minimum education and qualification will generally be
at BSc or equivalent level in Microbiology (or equivalent) with a minimum of 3 years in-depth experience in working as a microbiologist in the
manufacture of sterile products (medical devices or pharmaceuticals).
However, where there is extensive industrial or medical device user experience a lesser relevant qualification may be acceptable. Qualifications
should be a subject that, when taken along with their work experience, can be readily related to the scope of the technology or process in which
The previous work experience is most likely to be in the following:
- Working in closely related industries and the workplace such manufacturing;
- Carrying out microbiological testing of products and conducting sterilization validation studies.
Bosch Global Associates Ltd