CZ
Antal logo
PL EN CZ
Enloyd logo
EN HU

Oblíbené nabídky

Odpovědět

Technical Documentation Accessor

odkaz: /22/08/2020/MV
Vedoucí poradce: Monika Volčková
Bratislava (Bratislavský kraj)
Stálá práce 10. září 2020

Ve společnosti Antal se zabýváme náborem již přes 20 let. Díky tomu, že působíme v 10 specializovaných divizích, máme vynikající orientaci v současných trendech na trhu. Přesně určujeme konkrétní povahu práce, klasifikujeme klíčové dovednosti a potřebnou kvalifikaci. Naším posláním není jen najít kandidáta, jehož kompetence odpovídají požadavkům daného pracovního inzerátu, ale především najít pozici, která splňuje očekávání uchazeče.

For our client a global leader provider of quality, safety and sustainability solutions that specialises in testing, inspection, auditing, certification, training and knowledge services we are looking for a Technical Documentation Accessor/ Auditor/ Product Specialist

Responsibilites:

Assessment of Technical Documentation: Perform conformity assessments of regulatory submissions such as Design Dossiers and Technical Documentations to relevant safety principles and standard requirements.

Auditing (to limited extent): Perform regulatory audits of clients per European Medical Device Regulation (MDR), Medical Device Single Audit Program (US, Canada, Brazil, Japan, Australia), and International quality system standards (e.g. ISO 13485) as well as internal Notified Body criteria including all related tasks, such as scheduling, planning, reviewing corrective actions, preparing reports and audit documentation for submission to the certification committee of the Notified Body.

Project Management: Provide project management for customers. Project management potentially consists of issuing quotes, coordinating multiple projects, coordinating audit team, and answering client questions.

Communication / Customer Service: Communicate in a courteous and effective manner with internal and external customers in all circumstances including answering questions, relaying messages, and providing information with regard to standards, regulatory and technical requirements for compliance with standards and the respective regulatory system.

Reguirements

Minimum BSc degree in biomedical, electrical, or mechanical engineering or equivalent

Four years’ experience in medical device industry and two years’ work experience in design / product development / manufacturing engineering one of the following medical device product categories: Active Implantable Medical Devices, Ophthalmology, wound care products, Cardiovascular products, Absorbable Implantation Products, Functional Safety and Software

A relevant Master degree substitutes one year and a relevant PhD degree substitutes up to three years of four years of work experience

Sound knowledge in regulatory requirements, e. g. MDR (REGULATION (EU) 2017/745) and other related requirements

Sound knowledge in product-, technology- quality- or other related standards

Orientation towards the safety and performance of medical devices

Correctness

Ability to work in an intercultural environment

Ability to plan and organize work

Proficiency in MS Office

Common sense and pragmatism

Auditor according to ISO 13485 and MDR and CMDCAS and JGMP (a plus)

Sound knowledge in product-, technology- quality- or other related standards

Willingness to travel up to 20% (domestic and international)

Company on whose behalf the position is being filled

Hospitals, medical practice activities, other human health activities

Odpovědět