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QA Associate

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Engineering, Network

Projektbeschreibung

Job Description:
The Company is currently expanding its clinical and manufacturing efforts and is seeking a well-qualified individual to be responsible for The Company's quality system, control product and process documentation, and assure quality specifications and requirements are adequately addressed. This position will interface on a daily basis with the Engineering, Manufacturing, Purchasing, Regulatory, Clinical and R&D departments. They will also be required, from time to time, to interface with suppliers to either perform surveys, source inspections, First Article inspections or to verify corrective actions. This person may also interface with customers/regulatory agencies during onsite audits.
Tasks performed may include lab work, working on the manufacturing floor, and office tasks. Working at off site locations may be required on a periodic basis.

Essential Job Functions:

* Confers with engineers, managers, other departments and assists in resolution of product quality or quality system issues.
* Performs and verifies documents for completeness, format, and compliance with applicable federal, international regulatory requirements and The Company policies.
* Responsible for updating and maintaining international and domestic standards used and referenced in the development and maintenance of The Company products.
* Perform internal audits to meet requirements of the internal quality system.
* Assist in the creation and development of product labeling.
* Leads the MRB/CCB meetings.
* Reviews, releases, tracks, monitors and trends Nonconforming Material Reports (NCMRs), Change Orders, Complaint, RGAs and Corrective Actions.
* Responsible for closing Change Orders when implementation tasks are completed.
* Responsible for the distribution of all controlled documents to Engineering, Manufacturing and Quality Departments and external suppliers.
* Responsible for the creation and maintenance of Material Master numbering system.
* Ensures that all applicable employees have received and returned training documents. Verifies that all training records have been updated.
* Performs duties in compliance and ensures compliance with relevant QSRs, ISO regulations and the MDD for area of responsibility.
* Performing and completing various miscellaneous tasks when assigned.

Minimum Requirements:

* 1-2 years manufacturing experience, ideally in a medical manufacturing environment. 1 year of experience in Documentation Control preferred.
* Basic knowledge of FDA QSRs, ISO 9001, ISO 13485 and the MDD requirements for Inspection and Quality Control.

Essential Requirements:

* Listen and understand verbal and written instructions.
* Take the initiative to organize the workload.
* Ability to set priorities and work them through.
* Ability to work under tight deadlines.
* Good communication skills and a team-oriented attitude.
* Computer knowledge working within multi-level network platforms.
* Individual must be detail-oriented, accurate, well organized and able to work effectively under pressure and constant changing priorities.
* The employee must be able to develop and maintain positive relationships with employee population.
* The ideal candidate for this position must have a commitment to high quality standards.To find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    San Diego, California, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland