Beschreibung
Design Quality Assurance Manager
About us:ITech Consult AG is a certified ISO Swiss company with offices also located in Germany, Great Britain and Ireland. ITech Consult is specialised in delivering ICT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.
Reference No.: 916136NC
Role: Design Quality Assurance Manager
Industry: Pharmaceuticals
Location: Luzern und Region
Workload: 100%
Start Date: ASAP
Duration: Till 30.06.2017
Role:
-Represents Design Quality Assurance in project teams to achieve sustainable compliance of projects for the assigned work area and covering at least two component and/or system development areas (Hardware/Software/Consumables/Reagents/Sensors/Standalone Software)
-Provide design control quality support with a pro-active, business solution oriented approach, while collaboratively being involved in the generation, review and approval of design control documentation/deliverables during product development and product care activities
-Ensures that any design quality issues that may jeopardize the regulatory status of the projects and products in their work area are handled with the necessary priority and urgency
-Educate the business in quality topics
-Participation in the planning of design control deliverables and/or project team outputs
-Support design and milestones reviews during product development and product care activities Support external and internal audits and inspections as a subject matter expert
-Proactively gathering input and sharing output of compliance related topics with other relevant Quality (at least DQA) and Regulatory team members
Tasks and Responsibilities:
-A minimum of three years' experience in a quality, technical product support or development role, and functioning in a Matrix-managed environment
-Provide DQA Support for RMD Systems Activities in assigned area.
-Bachelor's Degree preferably in a technical/scientific discipline eg Chemical, Physical or Biological Sciences; Pharmacy, Microbiology, Medical (Device) Technology or Engineering
Specialized experience
-Training in Quality Management Systems, including but not limited to 21 CFR 820, ISO 13485 and related standards (certification desired but not required) or evidence of knowledge, work experience, and proven skills in medical device development (reagents, systems and devices) and related technologies (immunochemistry, molecular diagnostics, sequencing, biologics or PCR) or Quality Management Systems (advantage)
-A flexible and team-oriented personality with the ability to assert oneself, professional communication skills, and the ability to work under pressure in a fast-paced international environment
Languages: English and German fluently (written and spoken)
Should you find yourself suitable for this position then send your complete dossier using this link in the advert.
*Even if this position doesn't suit your profile we recommend that you send us your CV and share with us what you are exactly looking for.
Call us and discover the quality of our services for yourself. We are more than happy to meet with you for an individual consultation. Do not hesitate to contact us for further enquires
Our Pay rolling is referred by 98% of our freelancers as the best Pay rolling system in Switzerland. Do you require more information? Feel free to contact us.