Sterility Assurance Specialist Sterile Devices

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Schlagworte

Beschreibung

Start: ASAP or negotiable

Duration: 3.5 months (possibilities to extend)

Location: Zug

For a renowned medical devices company based in Zug, we are currently looking for 2:

Sterility Assurance Specialist Sterile Devices

Responsibilities:
. This position is responsible for the European Sterility Assurance activities. This position ensures compliance to the applicable Medical Device Directive (MDD), ISO 13485, ISO 14971, ISO 9001 and FDA (QSR) regulations as they apply to sterilization. Additionally to other applicable Sterilization and Microbial ISO and EN standards (esp. EN ISO 11137-x, EN ISO 11135), AAMI standards/reports and other guidance documents as required.

. This position provides Sterility Assurance oversight to ensure the adequacy of these activities and documentation in terms of regulatory compliance and technical soundness throughout the European manufacturing system. This should be accomplished by working closely with other Sterility Assurance Team Members in US and EU.
Detailed description:
. Create, review, correct and release any documents to cover the client's sterilization program (eg Gamma sterilization Program).
. Correspond with internal and external customers with special requests regarding the firm's sterilization program.
. Support and ensure sterility validations (eg dose establishing, dose audits, dose mappings) for all product families are remediated and following the current standards.
. Train PD, consultant and other personnel in basic sterilization and in sterilization procedures.
. Review all vendor sterility assurance validation protocols and reports to ensure regulatory requirements are met.
. Create internal validation and re-validation protocol and reports.
. Other duties/responsibilities as assigned by manager.
Skills & Experience required:
. Knowledgeable in applicable Medical Device Directive (MDD), ISO13485, ISO 14971, ISO 9001 and FDA (QSR) regulations.
. Well versed in government regulations and industry guidelines for sterilization (eg EN ISO 11137-x, EN ISO 556-2, EN ISO 11135) and microbiological control of medical devices.
. At least 5 years experience in gamma validation, preference with metal and plastic medical devices.
. Experience in ETO validation is an advantage.
. This position requires a high level of written and oral communication skills and the ability to interact with managers at all levels as well as personnel at the operating unit level.
. Working knowledge of applicable software, particularly Microsoft Office applications.
. Excellent organizational skills.
. Language: English needed and German would be an advantage.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Start
ab sofort
Dauer
3.5 months
Von
Michael Bailey Associates - Zurich
Eingestellt
26.02.2015
Projekt-ID:
858497
Vertragsart
Freiberuflich
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