Technical Planning Coordinator
Intertek Semko Notified Body / Administratörsjobb / Stockholm
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Vi hjälper våra kunder att se till att deras processer, produkter och system är säkra och håller den kvalitet som både myndigheter och kunder världen över förväntar sig. Det gör våra 42 000 medarbetare världen över genom att inspektera laster och fabriker, testa och certifiera allt från leksaker till medicinteknik, granska underleverantörer, certifiera ledningssystem, analysera livsmedel, oljeprodukter och kemikalier och utvärdera batterilösningar för elfordon. Bland mycket annat. Vi gör världen lite säkrare, helt enkelt!
Bringing quality and safety to life
About Us
Intertek is the trusted service provider to many of the world's leading brands, companies and governments, and has earned a reputation for accuracy, reliability, integrity, and technical competence.
Our Assurance, Testing, Inspection and Certification services take us into nearly every field, from textiles, toys and electronics, to building, heating, pharmaceuticals, petroleum, food, cargo scanning and medical devices.
In a world where a company's success depends on its reputation for quality, safety, and socially responsible products and processes, Intertek employees make a difference.
Join the team at Intertek and work with some of the best, brightest, and most inspiring people in the assurance, testing, inspection, and certification industry.
The Role and Responsibilities
This role has accountability to ensure the Medical Notified Body activities related to technical documentation are coordinated according to plans. This role has responsibility to provide support to the Notified Body's Planning team.
Further the role will also more specific include:
• Manage incoming customer enquiries and assign to appropriate team members to address the query. Client interface and first line of contact
• Assist in developing, maintaining and improving processes, procedures, forms and registers to enable the technical planning to run effectively and efficiently
• Maintain and update the Technical File Sampling plan which means to ensure the Technical File Sampling Plan is adhered to, with files called in on time and transferred appropriately to the Technical Documentation Operations Group.
• Control and monitoring of Vigilance, liaising with Technical Document Scheduling coordinators and Technical Planning specialists.
• Prepare customer agreements and amendments
• Management of customer data in iEnable (internal data base) and where applicable also on other company drives.
• Coordination of addition of products to scope from clients.
• Support EUDAMED database, including data entry and data verification.
• Giving data to invoicing for performed duties of the group
• Gather, monitor, report KPI information related to clinical processes and performance
The expectations of our employees are to drive continuous improvement and represent our value and give energy to peers.
Competencies, personal attributes and skills
The role holder should possess an appropriate experience in coordination of complex tasks. You must be able to demonstrate the capability to coordinate, plan and follow up. You have a keen eye for detail and is focused on delivering accurate and robust results within agreed timeframes. Advantageous: experience in Quality Assurance and/or Regulatory Affairs in the Medical Devices industry and have knowledge the EU Medical Device Directives and Regulations. These are not mandatory but advantageous experiences.
Further you have sound broad capabilities for basic computer skills (MS Word, Excel, PowerPoint, SharePoint and database management/maintenance). You also have proven skills for task management, scheduling, follow-up and data control for KPIs and operates ethically with the highest degree of professional integrity.
What we offer
Intertek is a safe workplace with collective agreements, benefit package with pension, health care contributions and parental leave allowance. We have flexible working hours and encourage a good working climate and satisfied employees.
The role is full time and based in Stockholm, Sweden.
Submit your application with resume and cover letter today, or as soon as possible. If you have any questions regarding the position, please contact Technical Planning Manager Pontus Gedda
pontus.gedda@intertek.com tel: 0709-609100
Varaktighet, arbetstid
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Publiceringsdatum2018-09-24ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-10-21
Klicka på denna länk för att göra din ansökanFöretagIntertek Semko Notified Body
AdressIntertek Semko Notified Body
Torshamnsgatan 43
16440 Kista
KontorsadressTorshamnsgatan 43
Jobbnummer 4362933
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