Quality Assurance / Regulatory Assurance Specialist

Manpower SA — TOLOCHENAZ
08.11.2019 | Executive po­si­tion | 100%

Introduction :

Référence filiales : 156-MORGES
Nom du conseiller : Bancon Quitterie
Nom de la filiale : 3
Adresse :
19, Grand-Rue
Morges
1110

Description de l'entreprise :
Manpower
Secteur d'activité : Chemistry & Life Sciences

Quality Assurance / Regulatory Assurance Specialist

Description:
Design Quality Assurance (85%) :- Participate in new product development projects by providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations. Key deliverables including, but not limited to product performance analysis on similar products, risk analysis, failure mode and effects analysis, essential requirements checklist, design verification / validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product- Review drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing, proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods. Recommend revisions to assure design requirements are specified in the appropriate detail and clarity to provide a successful design transfer. Review and approve engineering change requests. Review product verification and validation plans and approve reports. Design Controls/Quality SystemRegulatory assurance (15%)- Coordinates and prepares document packages for regulatory submissions for Product Development Europe activities- Supports project needs for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. - Compiles all materials required in submissions, license renewal and annual registrations.

Date d'entrée : 13-11-2019

Type de société : Entreprise privée

Reference : 149926-60-2

Date de publication : 2019-11-08 11:47:45

Profil recherché :
Master or Bachelor degree5 to 7 years of experience in the medical device industry, ISO 13485, MDD 93/42 and other regulations that may applyExperience in the application of production and process controls including process validation, process control plans and statistical process control.Experience representing their department during quality system auditsExperience in product mechanical evaluation & testing and GD&TFluent in EnglishQuickly available for a long term temporary assignment (min. 6 months)

Pays : Suisse

Lieu de travail : TOLOCHENAZ

Code postal : 1131

Catégorie : Affaires réglementaires;Production;Contrôle Qualité / Process;Ingénieur / R & D

Niveau d'études : Expérience professionnelle : Début du contrat : 13.11.2019Durée du contrat : Not specified
Conclusion :
Are you interested in this job? Please use our online form to apply. We look forward to receiving your application.

Manpower

Rue Winkelried 4Genève

Industry

Human resources / Personnel services

Year of foundation

1960

Labels (1)
Training Company
Training Company

Manpower

Rue Winkelried 4Genève

Industry

Human resources / Personnel services

Year of foundation

1960

Labels (1)
Training Company
Training Company
Salary

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