Quanto è utile/interessante questa discussione:
| Autore |
Discussione |
|
|
freemind1449
Nuovo Arrivato
1 Messaggi |
 Inserito il - 28 giugno 2006 : 20:05:15
|
Sondaggio:
IVD IN VITRO DIAGNOSTIC QUALITY MANAGER – Milan (Italy)
June 2006
Our client is one of the world’s largest semiconductor companies, leader in developing and delivering semiconductor solutions across the spectrum of microelectronics applications, based in Milan north-east area. From this company comes a powerful new molecular diagnostics tool for DNA amplification and analysis. The lab-on-chip brings the exponential power of the Polymerase Chain Reaction (PCR) into a cost effective and convenient format. Clinicians no longer need to compromise between sensitivity, specificity and speed.
The platform is based on a silicon chip that integrates all the functions needed to identify given oligonucleotide sequences in a sample, including micro-fluidic handling, a miniaturized PCR reactor and a custom micro-array. The chip is mounted on a 1”x3” plastic slide that provides the necessary mechanical, thermal, electrical and fluidic connections.
Responsibilities:
This IVD Quality Manager position will facilitate team quality and regulatory compliances related activities by regular communications with all functional areas. Signature and department authority for QC, QA, and QE. The position's responsibilities also include leading internal audits and audits with external suppliers to ensure all areas meet the necessary CE/FDA, ISO, IVD, and CLIA regulations, while maintaining internal policies and procedures, assist with correction of deficiencies, coordinate CAPA case for completion, and verify effectiveness of actions implemented. This position also participates/lead process/procedure development and improvement initiatives as they related to the Quality System. Cross training and cross-learning of Regulatory Compliance activities is expected. Ensures that all areas responsible for compliance activities align with that strategy and conform to policies and procedures. Responsible for the implementation and effectiveness of the compliance functional areas and systems. Oversees management of these areas through direct reports. Leads and supports the business by providing consistent Quality and Regulatory direction; assisting in key deliverables; and supporting compliance activities throughout the organization.
Qualifications:
Education: Bachelor's Degree in Life Science or equivalent. Language Skills: Must be proficient in writing, and communicating in the English language.
Experience:
1) 5 or more years of relevant FDA regulated industry experience with at least 2 years as a Quality or Regulatory Compliance Manager.
2) Desired experience as an auditor and escort for Federal and State inspections, ISO/ European Directives/ Notified Bodies, and U.S. FDA Quality System Regulatory Compliance inspections.
3) Desired technical knowledge of molecular biology and genetic testing laboratory practices (CLIA, ASR, IVD).
4) Desired experience with product design controls during development of nucleic acid-based assays for disease detection and diagnosis or development of pharmaceutical products in a regulated environment, preferably in a company manufacturing diagnostics products for the clinical lab and/or doctor’s office market.
5) Desired experience in planning, coordinating and documenting controlled studies, including protocols.
6) Desired training and experience in basic statistical analysis tools and Design of Experiments (DOE) and Six Sigma methodologies preferred.
7) Understanding of the methods used by regulatory authorities to determine compliance by medical device manufacturers.
8) General management skills and experience in the manufacture of IVD medical devices and quality system requirements and processes.
If you are interested in this position, please, apply at info@studiomazzitelli.it adding the sentence "I grant permission for my personal information to be used, ref. law 196/2003". We search for men and women according to Italian law 903/77.
Thank you for applying to Studio Mazzitelli, we aim to respond as promptly as possible to your application, however, due to the high level of CV's we receive we are only able to respond to applicants whose profile matches our Clients requirements.
Authorization from Ministry of Labour n° 416/RS.
|
|
|
|
|
|
dallolio_gm
Moderatore
Prov.: Bo!
Città: Barcelona/Bologna
2445 Messaggi |
Inserito il - 29 giugno 2006 : 09:50:58
|
ciao,
non sono sicuro che sia una buona idea lasciare che vengano postati annunci di lavoro su questo forum.
In fondo ci dovrebbe essere una sezione apposita (in via di costruzione) e poi, io personalmente non ho esperienza nel giudicare la bonta' di simili annunci.
Per esempio, che cos'e' l'autorizazzione del 'Ministry of labour n. 416/RS'? E poi, perche' questa societa' chiede di rimanere anonima?
Vorrei invitare tutti gli utenti del forum a riflettere sul fatto che, rispondendo a questo annuncio, mandate tutti i vostri dati (curriculum, codice fiscale, residenza, mail, etc..) ad una societa' sconosciuta, che per quello che si sa potrebbe essere uno spammer a caccia di indirizzi oppure una setta di scientology in cerca di seguaci da sacrificare. |
Il mio blog di bioinformatics (inglese): BioinfoBlog
Sono un po' lento a rispondere, posso tardare anche qualche giorno... ma abbiate fede! :-) |
 |
|
| |
Discussione |
|
|
|
Quanto è utile/interessante questa discussione:
| MolecularLab.it |
© 2003-18 MolecularLab.it |
|
|
|
ricerca di un IVD Quality Manager
Didattica
