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Budget:

6.000 - 10.000

Geposted am

18.04.18 09:58

Kunde

sar***

Standort des Freelancers

Deutschland

Dieses Projekt wurde geschlossen

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Beschreibung:

Für unseren Kunden, ein Unternehmen aus der Branche Medizintechnik, suchen wir ab Mai zum Einsatz in Hamburg einen

Manufacturing Engineer (m/w) auf freiberuflicher Basis

Die Position ist auf freiberuflicher Basis ab Ende Mai bis vorerst zum 31.12.2018 zu besetzen.

Aufgaben:

- Responsible for manufacturing processes and related equipment with overall knowhow of the entire value stream, incl. related people, process, equipment, and product

- Applying effective project management

- Responsible and accountable as leader or team-member for the autonomous validation of processes, product changes, test methods, equipment and materials qualifications, pFMEAs and all other product and process validation related activities

- Applying the Quality procedures & standards of Change Management principles

- Organizing and performing process validations, including DOEs, IQ,OQ and PQ protocols and reports, creation or modification of all affected specifications of test methods and manufacturing processes, computer software validations and application of statistical tools to support these validation activities

- Responsible for creation of quality and equipment documentation for manufacturing processes and products from these processes

- Preparing and performing Risk Management activities, Risk Assessments (pFMEA) and environment, health and safety evaluations according to internal standards and legal requirements

- Performing and supporting failure investigations of non-conformities together with process quality responsible persons

- Responsible for defining calibration requirements and overall suitability of measurement devices used in manufacturing and testing processes according to the relevant standards and quality regulations

- Develop, upgrade and validate testing routines to be applied by manufacturing and lab staff during the manufacture and validation of products and during storage stability studies

Anforderungen:

- Experience in GMP related working environment

- Medical Device experiences/ Pharma

- Statistic knowledge (Minitab)

- Language knowledge of German & English

Klingt das nach einem interessanten Projekt für Sie? Gerne stehen wir Ihnen auch telefonisch unter 0[OBSCURED] für weitere Fragen zur Verfügung.

Sarah Simon

Kelly Services Hamburg

T: 0[OBSCURED]

[OBSCURED]