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Supplier Quality/Validation Engineer JNJKJP00035616 (m/f/d)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Engineering, Design, Engineer, Blueprint
Projektbeschreibung
REFERENCE NUMBER:
406588/29
MY DUTIES:
-Conduct process validation and verification activitiers in assigned projects within scope (Titanium Anodization, Electropolishing, Passivitation, Sterilit and others)
-Support Change Control Management and Manufacturing/Product Transfer as well as outsourcing initiatives
-Assure compliance with ISO 13485 quality requirements and alignment with Quality System Requirements (QSR)
-Manage CAPAs, deviations and execute improvements
-Communicate proactively and professionally with internal and external partners in order to guarantee project quality
-Provide regular reports and updates to project leader and various teams
MY QUALIFICATIONS:
-Strong engineering skills with working knowledge of process validation/verification activities
-Experience in Change Control, Manufacturing/Product Transfers, Outsourcing Initiatives
-Knowledge of the QSR, Design Controls, and ISO 13485 quality requirements
-Profound related experience is required, preferably within a regulated environment (e.g. FDA, ISO 13485 regulated)
-Experience conducting Process / Design Failure Mode Effects and Analysis
-Knowledge on Statistical techniques and methods, capability studies
-Experience in Control Plans, inspection methods and techniques, First Article Inspection, Test Method Validation/ GR&R
-Experience with Blueprint reading/literacy including Geometric Dimensioning and Tolerance (GD&T)
-Ability to work independently and partner with a cross-functional team (supplier, R&D, Regulatory, Manufacturing, and Purchasing etc)
-Excellent negotiation, decision-making, and interpersonal skills that foster conflict resolution as it relates to technical situations is desired
-Excellent written and oral communication skills
-Language: English must plus German and / or French highly desired
-Travel within Switzerland up to max. 50%
MY BENEFITS:
-A very renowned company
-A highly motivated team and an open way of communication
-You will work in an international environment
PROJECT INFORMATION:
-As a modern company, our client manages to constantly develop further and break new ground
ABOUT HAYS:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
406588/29
MY DUTIES:
-Conduct process validation and verification activitiers in assigned projects within scope (Titanium Anodization, Electropolishing, Passivitation, Sterilit and others)
-Support Change Control Management and Manufacturing/Product Transfer as well as outsourcing initiatives
-Assure compliance with ISO 13485 quality requirements and alignment with Quality System Requirements (QSR)
-Manage CAPAs, deviations and execute improvements
-Communicate proactively and professionally with internal and external partners in order to guarantee project quality
-Provide regular reports and updates to project leader and various teams
MY QUALIFICATIONS:
-Strong engineering skills with working knowledge of process validation/verification activities
-Experience in Change Control, Manufacturing/Product Transfers, Outsourcing Initiatives
-Knowledge of the QSR, Design Controls, and ISO 13485 quality requirements
-Profound related experience is required, preferably within a regulated environment (e.g. FDA, ISO 13485 regulated)
-Experience conducting Process / Design Failure Mode Effects and Analysis
-Knowledge on Statistical techniques and methods, capability studies
-Experience in Control Plans, inspection methods and techniques, First Article Inspection, Test Method Validation/ GR&R
-Experience with Blueprint reading/literacy including Geometric Dimensioning and Tolerance (GD&T)
-Ability to work independently and partner with a cross-functional team (supplier, R&D, Regulatory, Manufacturing, and Purchasing etc)
-Excellent negotiation, decision-making, and interpersonal skills that foster conflict resolution as it relates to technical situations is desired
-Excellent written and oral communication skills
-Language: English must plus German and / or French highly desired
-Travel within Switzerland up to max. 50%
MY BENEFITS:
-A very renowned company
-A highly motivated team and an open way of communication
-You will work in an international environment
PROJECT INFORMATION:
-As a modern company, our client manages to constantly develop further and break new ground
ABOUT HAYS:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik