Join one of the most promising companies in the Swiss MedTech environment.
Abionic is committed to revolutionize the world of in vitro diagnostics with rapid universal point-of-care solutions. Based on disruptive technology, Abionic is offering the world of healthcare a novel point-of-care diagnostic tool and thereby fills patients’ unmet needs.
Abionic is an innovative company located in the Lausanne area, Switzerland. It is ideally positioned at the boundaries of medical technology, biotechnology and nanotechnology. Abionic is a fast-growing company with ambitious objectives, spin-off from EPFL and a proud member of Health Valley Switzerland.
We are looking for a Quality Control Engineer to complete our team
In this position, you will be part of the company’s Quality Control team currently comprising a QC Engineer and four Laboratory Technicians. You will report directly to the Head of QC and will be responsible for the Quality Control of our products. You will also work in close contact with Production and NPI teams to develop, validate and implement new quality methods. The tasks associated to this position are:
- Participate in the effort to control the quality of materials and products (incoming inspections, in-process controls and final controls for batch release) ensuring a close partnership with Production.
- Support, coach and help on the supervision of the Laboratory Technicians in their operational activities.
- Perform statistical analysis to analyze trends, determine assay validity and acceptance criteria for Quality Control methods and procedures.
- Develop and/or optimize existing methods and procedures to verify that materials and products meet specified requirements.
- Work closely with Production to investigate, conduct root cause analysis, recommend corrective actions for processes and products.
- Review test results, write technical reports, and support documentation of CAPAs, deviations and non-conformities.
- Provide support in drafting, reviewing and revisioning of operational procedures concerning Quality Control tests.
- Collaborate closely with Test Development, NPI and Production teams to ensure compliance with specifications and support transfer of new products from development to routine manufacturing.
- Develop and maintain KPIs on your scope of responsibilities.
- Master’s degree in Life Sciences (or related) with 3+ years of relevant professional experience in Quality Control, ideally in the diagnostic, medical device or biomedical industry.
- Practical bioanalytical/biochemical skills and experience with immunoassay or other protein biochemistry is needed.
- Working under a Quality Management System, with practical knowledge of the ISO 13485 standard is required.
- Attention to details, methodical and meticulous in approaching problems, data-driven with high commitment to quality.
- Ability to prioritize, manage multiple tasks with agility to deliver timely results.
- Ability to take decisions without full dataset, on a risk-based approach.
- Ability to perform work independently and in cross-functional team, in a fast-paced environment.
- Excellent oral and verbal communication skills, mastery of technical writing.
- Fluent orally in English and French. English written fluency is mandatory.
- Basic computer skills (Windows, MS-office)
She/He must be motivated to contribute to the development and production of a highly innovative diagnostic platform as part of our young, talented and ambitious team.
A challenging job within an exciting modern environment within a MedTech company, Integration in a dynamic and growing team, A highly innovative environment, An opportunity to improve healthcare.
Starting date: Immediately
Activity rate: 80% – 100% (to be discussed)
You want to work in an innovative environment and to integrate a dynamic team? Please send us your application (CV, cover letter, and work certificates when applicable) to email@example.com, indicating “QC Engineer position” in the headline.