Coronavirus: Deine Gesundheit liegt uns am Herzen. Bitte achte auf das richtige Verhalten und folge den Empfehlungen des Bundes.

QA/RA Engineer

 — CH 1015 Lausanne
18.02.Fach­verantwortung100%

QA/RA Engineer

OPEN POSITION


QA / RA Engineer


Position type Permanent Fixed-term Internship Hourly
Percentage Full time 100% Part-time: %
Starting date April 2020
Location Lunaphore Technologies SA headquarters in Lausanne


Lunaphore Technologies is a life-sciences company delivering products based on a
microfluidic technology to analyze tissue samples for cancer research and diagnostics.
Lunaphore is seeking a highly motivated candidate to join our team and contribute
directly to the development and growth of the company.


Summary


Lunaphore is seeking a highly motivated candidate to contribute to our company with
his/her experience in quality assurance and regulatory affairs by managing and
improving Lunaphore’s Quality Management Systems and ensuring that the company’s
products meet all necessary regulatory requirements.


Role/Responsibilities


The Quality Assurance/Regulatory Affairs (QA/RA) Engineer is responsible for:


Managing and improving the Quality Management System (QMS) of the
company in compliance with ISO9001, ISO13485 and American 21 CFR Part
820.
Ensuring compliance of the IVD and non-IVD products with regulatory and
quality requirements.
Performing technical quality inspections of Lunaphore’s products.
Frequently interacting with Lunaphore’s critical suppliers.
Meeting quality and regulatory-related deadlines as well as ensure up-to-date
documentation.
Participating to internal and external audits.
Frequently interacting with the different departments to ensure compliance of
the product development to regulatory and quality requirements.
Lunaphore Technologies, EPFL Innovation Park, Building C, CH-1015 Lausanne
www.lunaphore.com
Supporting QA/RA department for RA activities.
Reporting to the QA/RA Manager on a regular basis.
Supporting the QA/RA Manager in contacting external parties such as notified
body, competent authorities or consultants.


Skills


You have an excellent understanding of quality and regulatory standards
(experience with ISO13485, 21 CFR Part 820 and Directive 98/79/EC is a strong
plus).
You have experience with implementation or maintenance of a Quality
Management Systems.
You have the ability to adapt in a constantly changing environment.
You like to interact with people in a multi-disciplinary environment.
Excellent organizational skills, attention to detail, ability to manage deadlines,
multiple priorities, and deliver results with limited supervision.
An excellent command of written and oral English. French is a strong plus.
You have excellent knowledge of Microsoft Office software programs (Word,
Excel, PowerPoint).


Preferred qualifications


A degree in a Life sciences/Engineering related field and/or a certificate in
Quality Assurance and Regulatory Affairs.
2-3 years of experience in Quality Assurance and/or Regulatory Affairs for
Medical Devices / In Vitro Diagnostics Medical Devices.
Internal Auditor certificate.


We offer


A young and strongly growing high-tech scale-up company.
An international working environment with a high level of diversity and a strong
network.
A highly interactive team with strong personal and technical qualities.


Contact information


If you are interested, send your application to: human.resources@lunaphore.com


Lunaphore Technologies, EPFL Innovation Park, Building C, CH-1015 Lausanne
www.lunaphore.com

Info

Info

18.02.2020
Fach­verantwortung, 100%

Firma

Branche:Medizinaltechnik
Offene Stellen:10 Jobs
Standort:EPFL Innovation Park Building C
1015 Lausanne
Website:http://www.lunaphore.com
Salary

Lohncheck

Nutze den Service von jobs.ch und finde heraus, ob du bekommst, was du verdienst.
Diese Webseite benutzt Cookies, um den bestmöglichen Service zu bieten. Weitere Informationen sind in unserer AGB und in der Datenschutzerklärung zu finden.