Project Quality Assurance Engineer
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 Write an email no later than 21.04.2024.
Template: QMS-TEMP-0021 Ver. 3
CH-1202 Genève / Genève
