Personal data
title, name, first name / date of birth
nationality / languages
Field of operation valid for scope’s: MD
The above named person is
a full-time employee employed by QS Zürich AG
a full-time/part-time internal employee of the applying organization
an external employee on freelance-basis/subcontractor
and is appointed as
expert for order processing employed by QS Zürich AG / technical expert in an auditing team
expert assessing technical documentations or design dossiers / reviewer/final reviewer
expert in clinical evaluation assessments
General requirements / requirements
QSZ / profile
expert / comments
Successful completion of a bachelor university degree or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, natural science or engineering
4 years professional experience in MDD field or closely related industry (e.g. industry, audit, healthcare, research experience) whilst two years of this experience shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed
Regulatory requirements of dir. 93/42/EEC, quality management system requirement in particular of standard EN ISO 13485, risk management (ISO 14971, FMEA methods), understanding of relevant guidance documents (MEDDEV, NB-MED, IMDRF), harmonized standards.
Preferably fulfil the qualification criteria for 3rd party auditors or experience as 2nd party or internal auditor
At least 3 years of professional experience in specialized area, of which at least 1 year with responsibility in specialized area.
Education / requirements
QSZ / profile
expert / degree/qualification
biology or microbiology;
chemistry or biochemistry;
computer and software technology;
electrical, electronic, mechanical or bioengineering;
human physiology;
medicine;
pharmacy;
physics or biophysics.
Language skills: (verbally and in writing) / requirements
QSZ / profile
expert / comments
German
English
French
Specific knowledge: / requirements QSZ / profile expert /
/ Training or experience /
specif-cation / design / validation / use / comments /
Clinical tests/evaluation/studies / -- / -- / --
Risks evaluation and side effects / -- / -- / --
Sterilisation
training and expertise in auditing quality systems;
training and expertise in process validation;
training in the application of current harmonised sterilisation standards relevant to the sterilisation methods being assessed;
practical experience of auditing sterilisation processes, relevant to the sterilisation methods being assessed;
training in the application of current environmental control standards;
practical experience of auditing controlled environment areas.
biocompatibility or clinical data / -- / -- / --
Medicine or veterinary medicine;
Biology or toxicology;
Chemistry or Biochemistry (biocompatibility only);
Materials or biomaterials science (biocompatibility only).
a sound knowledge of the fundamental principles of the assessment of biocompatibility or clinical data for medical devices;
a sound knowledge/training in the current harmonised standards and guidance documents relevant to biocompatibility or clinical assessment for medical devices;
practical experience in conducting or assessing preclinical or clinical trials or data.
Specific knowledge: / requirements
QSZ / profile
expert / comments
Cleanroom technique and validation
Bio burden
Biological teste/evaluation
Chemical tests/evaluation
Physical tests/evaluation
Clinical tests/evaluation
Cleaning and disinfection/hygiene and microbiology
Process validation
Telemetry
EMC
Software validation
Product/packaging stability and tests
Ergonomics
Material techniques
Welding
Knowledge and skills in EA scopes: / requirements QSZ / profile
expert / comments /
EA 4 / textile processing
Storage, processing (preparing, spinning, weaving, post processing), packaging, internal and external transport
EA 12 / chemical processing
mix / synthesize (batchwise or continuously), separating, cleaning, drying, bottling, storing
EA 13 / pharmaceutical processing
mix / synthesize (batchwise or continuously), separating, cleaning, drying, bottling, packaging, storage
EA 14 / plastic processing
Melting, forming, stamping, gluing, spraying, blowing, foaming, laminating, machining, packaging
EA 15 / glass/ceramic processing
mechanical processing
EA 18 / machinery/mechanical processing
Development, design, purchasing, testing, storage, transport, assembly, welding, coating
EA 19 / electronic/optics processing
Development, production, installation, maintenance, Populating, soldering, grinding, stamping, surface coating
EA 23 / other manufacturing
Woodworking, metalworking, plastics processing, surface treatment
EA 29 / distribution
Purchasing, storage, sales, maintenance, repair, disposal
Work Experience: / requirements QSZ / profile
expert / comments /
closely related industries and the workplace such as research and development, manufacturing;
the application of the device technology and its use in health care services and with patients;
testing the devices concerned for compliance with the relevant national or international standards;
conducting performance testing, evaluation studies or clinical trials of the devices.
Remarks:
For completeness and correctness
______date /
______
date
______
signature expert /
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signature QS Zürich AG
File Name/Version creation date/author change approval date/process owner
FO 252-06-e MD self assessment expert_vers02 11.08.15 / em 15.08.15 / bel page 1 of 3