Project Quality Assurance Engineer

vor 1 Monat

CH Genève Wyss Center for Bio and Neuro Engineering Vollzeit

Job Description

Title: Project Quality Assurance Engineer
Position: Fixed term contract 3 years (100%)
Posted :02/04/2024
Location: Wyss Center for Bio and Neuroengineering, Campus Biotech, Geneva Switzerland

About the Wyss Center for Bio and Neuroengineering, Geneva, Switzerland
The Wyss Center is an independent, non-profit, research organization that innovates and accelerates
technologies and therapies to transform the lives of people with neurological and mental health disorders.
The Center pursues transformational technologies in artificial intelligence, bio- and neuroengineering to
restore essential neural functions and deliver precision therapeutics for people with debilitating neurological
and mental health disorders.
Based at Campus Biotech in Geneva, Switzerland, the Wyss Center partners with faculty, clinicians and
industry, in Switzerland and internationally, to drive innovation and maximize clinical impact.
The Wyss Center was established by a generous donation from the Swiss entrepreneur and philanthropist
Hansjörg Wyss in 2014. Additional resources from funding agencies and other sources help the Wyss Center
achieve its mission.

About the Position
The Project Quality Assurance (QA) Engineer will work both independently and collaboratively at the Wyss
Center to facilitate the development of advanced implantable neurosensing and neuromodulation devices
that are designed to collect real-time neural signals, to transmit multichannel recordings and to provide closed
loop control signals for a range of applications.

More specifically, the individual will work to support projects, as part of the Wyss Center’s mission to develop
and translate to the market innovative medical devices and therapies.

The ideal candidate is a key player in the Wyss Center team, maintaining a compliant Quality Assurance
processes according to ISO 13485 and 21 CFR 820 for medical devices (ranging from Class I Software as Medical
Devices up to Class III medical systems consisting of implantable and wearable medical device components).
The medical devices are designed and developed and brought up to clinical trial by the Wyss Center.

They will report directly to the Center’s Quality Assurance Manager.

Key responsibilities
In their position, the Project Quality Assurance (QA) Engineer will have a broad set of responsibilities which
includes:
– Support assigned project(s) from development up to clinical trial: responsible to ensure effective
design control activities during the product life cycle and review deliverables from the Design Control
process including Design History File.
– Support assigned project(s) Risk Management activities in the design and development and
manufacturing phases.
Template: QMS-TEMP-0021 Ver. 3

– Lead assigned project(s) Usability activities.
– Support computer software validation used for the monitoring and measurement of requirements
and used in the Quality Management System.
– Support maintenance of continuous improvement of the Quality Management System (ISO 13485):
internal audits, management review, nonconformance, CAPAs.
– Conduct and support key supplier’s audits.
– Support the Quality Manager in the operational activities in neurotechnology, neuroimaging and
neurobiology projects (good practices).

Required competence and experience:
– MS in Engineering or relevant Life Science discipline, with 8 years of experience in a similar position in
the medical device industry (preferably with class III or class IIb medical devices)
– Detailed understanding of the EU, Swiss and USA medical device regulations, including the MDR
2017/745/EU, the FDA 21 CFR Part 820 and ISO 13485 requirements
– Experience with maintenance of Quality Management Systems and Processes for Medical Devices
– Demonstrated skills in risk management (ISO 14971) and documentation structure compliant with
standards and guidelines of the medical device industry (e.g. technical documentation, design history
file, Investigational Device Exemption)
– Experience and/or specialization in one or more of the following areas:
▪ Medical device software - IEC 62304
▪ Application of usability engineering to medical devices – IEC 62366-1
▪ Medical electrical devices – IEC 60601 series (nice to have)
▪ Active implantable medical devices – ISO 14708 series (nice to have)
– Comfortable working autonomously but also a team player
– Strong at taking initiative, fast learner, enthusiastic, curious
– Very high attention to detail
– Fluent in English; proficiency in French a plus
–
Additional competence (not required, but nice to have)
– Experience or interest in neuroscience
– Experience with CE marking, FDA clearance and/or approval

To apply, please send your CV and cover letter to HR@wysscenter.ch no later than 21.04.2024.

Template: QMS-TEMP-0021 Ver. 3

  • Quality Assurance Engineer

    vor 2 Wochen

    CH-8604 Volketswil Hapa AG Vollzeit

    Hapa AG, a leading provider of cutting-edge printing machines for packaging solutions, specializing in the pharmaceutical industry, is seeking a highly skilled Senior Production Quality Assurance Engineer to join our dynamic team. As a crucial member of our organization, you will play a pivotal role in ensuring the quality and reliability of our production...

  • Group Quality Assurance

    Vor 2 Tagen

    CH-8340 Hinwil BELIMO Automation AG Vollzeit

    Ihre AufgabenBelimo is an innovative publicly traded Swiss clean-tech company with over 2000 employees worldwide and numerous international subsidiaries and distribution companies. As global market leader in the development, production and sales of valves, actuators and sensors for controlling heating, ventilation and air-conditioning systems, we support our...

  • Quality Specialist

    vor 3 Wochen

    CH-8005 Zürich On AG Vollzeit

    ‹ Back to jobs Quality Specialist Location: ZurichApply for this roleCosting & SourcingCosting & Sourcing In short As our Quality Specialist you will be working in the field of quality and warranty management and in this role you will be innovating the way we do things to make On smarter, more agile and to continuously improve our products. You will be in...

  • Expert Quality Compliance

    Vor 4 Tagen

    Genève, Schweiz Randstad Vollzeit

    JobdescriptionFor our client Merck in Aubonne, we are looking for a Expert Quality Compliance (m/f/d) for a period of 12 months.Your role:As member of the Quality System & Compliance group, you willParticipate in continuous improvement of the site Quality Systems and in daily operational activitiesSupport Risk Management activitiesSupport Quality monitoring...

  • Senior Specialist

    vor 1 Monat

    CH-8005 Zürich On AG Vollzeit

    ‹ Back to jobs Senior Specialist - Quality Location: ZurichApply for this roleCosting & SourcingCosting & Sourcing In short As our Senior Quality Specialist you will be working in the field of quality and warranty management. In this role you will be innovating the way we do things to make On smarter, more agile and to continuously improve our products....

  • Project Engineer Automation

    vor 1 Monat

    CH-6010 Kriens ANDRITZ HYDRO AG Vollzeit

    Job title:  Project Engineer AutomationJob family:  Project & Site Management Business area:  Hydropower Contract location:  Kriens, Lucerne, CHWorking location:  Kriens Location type:  Office Location / Office-based Contract type:  Permanent Job description:  ANDRITZ HYDRO AG ist der führende Anbieter im zukunftsträchtigen Markt des Umbaus und...

  • Senior Data Engineer

    vor 1 Monat

    Genève, Schweiz SGS SA Vollzeit

    We are the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world. Wherever you are, whatever your industry, our experts worldwide...

  • Project manager

    vor 20 Stunden

    CH- Genève International Air Transport Association (IATA) Vollzeit

    Employment Type: PermanentContract Duration: At IATA, we speak for the airlines of the world, serving and supporting over 300 of them across all continents. We are passionate and knowledgeable about the aviation industry, and we strive to make it safer, smarter, more sustainable and more inclusive. We celebrate diversity and inclusion in our workforce, and...

  • Project manager

    vor 17 Stunden

    CH-1215 Genève International Air Transport Association (IATA) Vollzeit

    Employment Type: PermanentContract Duration:  At IATA, we speak for the airlines of the world, serving and supporting over 300 of them across all continents. We are passionate and knowledgeable about the aviation industry, and we strive to make it safer, smarter, more sustainable and more inclusive. We celebrate diversity and inclusion in our workforce,...

  • Intern, Performance Monitoring and Safety Risk

    vor 4 Wochen

    CH- Genève International Air Transport Association (IATA) Vollzeit

    Employment Type: InternshipContract Duration: 6 monthsAt IATA, we speak for the airlines of the world, serving and supporting over 300 of them across all continents. We are passionate and knowledgeable about the aviation industry, and we strive to make it safer, smarter, more sustainable and more inclusive. We celebrate diversity and inclusion in our...

  • Digital project manager

    vor 3 Wochen

    Genève, Schweiz Richemont Vollzeit

      Digital project manager – MICHELANGELO FOUNDATION     As the Senior Digital Project Manager you are responsible for all aspects of the Michelangelo Foundation’s digital initiatives. This encompasses both the Michelangelo Foundation website the Homo Faber website(s) and all digital marketing channels. Your role is to collect, understand...

  • Client Relation Center Tools

    vor 4 Wochen

    Genève, Schweiz Richemont Vollzeit

    ARE YOU A GOOD MATCH? You have experience in Retail or Client Relation Centers (CRC)? You have affinity for luxury? You have good experience with systems like Salesforce? You have already work on retail training strategies? You have clear understanding of the digital path to purchase? You are able to understand your environment in order to...

  • Field Application Engineer

    vor 2 Wochen

    Genève, Schweiz PICARRO Vollzeit

    Picarro is looking for a customer-facing Field Application (FAE)/Technical support Engineer (TSE) to become a key member of our Energy Team in Switzerland and contribute to the development in Europe.She or he will have a hands-on approach, a strong technical acuity, and a willingness to drive customer satisfaction. This person will be responsible for...

  • Field Application Engineer

    vor 2 Wochen

    Genève, Schweiz PICARRO Vollzeit

    Picarro is looking for a customer-facing Field Application (FAE)/Technical support Engineer (TSE) to become a key member of our Energy Team in Switzerland and contribute to the development in Europe . She or he will have a hands-on approach, a strong technical acuity, and a willingness to drive customer satisfaction. This person will be responsible for...

  • Field Application Engineer

    vor 2 Wochen

    Genève, Schweiz PICARRO Vollzeit

    Picarro is looking for a customer-facing Field Application (FAE)/Technical support Engineer (TSE) to become a key member of our Energy Team in Switzerland and contribute to the development in Europe.She or he will have a hands-on approach, a strong technical acuity, and a willingness to drive customer satisfaction. This person will be responsible for...

  • On-Board Computing Engineer

    vor 1 Monat

    CH-8600 Dübendorf Akademische Raumfahrt Initiative Schweiz (ARIS) Vollzeit

    Are you fascinated by space?Do you wonder what is possible when academia and industry work together?Would you like to join a team that makes systems made for space?If the answer is yes, yes and yes, we would love to hear from you! CubeSat – On-Board Computing Engineer ARIS is a student initiative based at ETH Zürich (Dübendorf) and inspires students...

  • Field Application/Technical support Engineer

    vor 2 Wochen

    Genève, Schweiz PICARRO Vollzeit

    Picarro is looking for a customer-facing Field Application (FAE)/Technical support Engineer (TSE) to become a key member of our Energy Team in Switzerland and contribute to the development in Europe.She or he will have a hands-on approach, a strong technical acuity, and a willingness to drive customer satisfaction. This person will be responsible for...

  • Senior Project Manager

    vor 4 Wochen

    CH-8908 Hedingen Kolb Distribution AG Vollzeit

    Senior Project Manager (100%) Your mission Lead and successfully execute complex, strategic company projects and programs across the different locations of the KLK Kolb Group (CH, NL) Ensure that implemented solutions meet regulatory and contractual requirements Collaborate with internal stakeholders to define and document project scope, deliverables...

  • Senior Sap/etrm Specialist

    vor 3 Wochen

    1202 Genève, Schweiz LITASCO SA Vollzeit

    Job Purpose SummaryThe primary purpose of the Senior SAP/ETRM Specialist is to provide expertise within his/her specialized area, to implement, maintain and support related business processes in the SAP ETRM system (hereinafter referred to as the “system”), participate in the projects and change management process of the system.LITASCO has invested to...

  • Senior SAP/ETRM Specialist

    vor 2 Wochen

    1202 Genève, Schweiz LITASCO SA Vollzeit

    Job Purpose SummaryThe primary purpose of the Senior SAP/ETRM Specialist is to provide expertise within his/her specialized area, to implement, maintain and support related business processes in the SAP ETRM system (hereinafter referred to as the “system”), participate in the projects and change management process of the system.LITASCO has...