Medical Device Software Quality Expert

RM IT Services GmbH

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

Western Europe,--Basel,Basel,

Key Skills :

Medical Device Software Quality Expert

Salary :

Market Rate

Date Posted :

24 Jun, 2021

Company Name :

RM IT Services GmbH

Location1 :


Job Category :

Information Technology Jobs

Experience :


Job Type:


Travel Amount:



Senior Quality Expert / Compliance Lead vacancy for a globally operating Stein based company in the pharmaceutical sector.
Your experience/skills:

* Academic degree in a scientific field paired with medical device software background
* At least 3 years of relevant experience in managing projects in compliance with ISO 13485, 21 CFR part 820 / part 4, IEC 62304, IEC 82304, ISO 14971, IEC 62366, MDD/MDR, GDPR and other relevant standards and guidances related to medical device software
* Excellent knowledge of cGMP, medical device software regulations, standards and guidelines as well as well-versed with medical device software development and life-cycle management
* Sound scientific, technical and regulatory knowledge in a specific area combined with outstanding analysis and evaluation of GMP compliance
* Outstanding organizational skills paired with ability to work in cross-functional teams including Quality, Technical Development, Regulatory, Human Factors, Risk Management, IT and other functions
* Languages: English, fluent in written and spoken, German or French are advantageous

Your tasks:

* Providing QA functional expertise in the review of QMS processes for compliance to regulations, standards and guidelines related to Medical Device Software
* Managing portfolio of assigned projects, supporting a discipline and assuring functional expertise in area of responsibility for medical device software
* Ensuring the development and commercialization of new medical device software products including web-based and mobile applications as well as their maintenance through its lifetime in compliance with medical device, software and data security regulations and standards
* Meeting internal and external guidelines regarding quality, safety and security lines such as quality manuals, regulatory cGMP guidelines, health authority requirements, international standards, SOPs and HSE
* Improving the overall quality of medical device software, tools and procedures, including peer reviews as well as administrating quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies

Start: ASAP
Duration: 12MM+
Location: Basel, Switzerland
Ref.Nr.: BH16696

Does this spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
New to Switzerland? In case of a successful placement, we support you with:

* All administrative questions
* Finding an apartment
* Health- and social insurance
* Work permit and much more

Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.

Company Name:

RM IT Services GmbH


Hackescher Markt 2-3,


Staffing Firms







100 - 499


Pharmaceutical Recruitment

Phone No. :


Professional Resources, Professional Services Since its establishment in 1998, the RM Group has developed to become one of the leading companies in the field of IT Resources Management in Switzerland. As a specialised recruitment agency, we find highly qualified experts for your projects. This is the basic requisite for the targeted development of IT strategies and for the practical implementation of IT projects. The RM Group is among the few significant Swiss recruitment agencies which fulfills all requirements related to compliance and quality assurance per ISO 9001, ISO 14001, GoodPriv@cy® and EcoVadis certification.

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