20.08
2024
Quality Engineer Limula SA is a Life Science Tools company based in Lausanne, Switzerland. Our mission is to make highly personalised cell therapies accessible to the patients in need, at reasonable cost, wherever they are. To achieve this goal, our multidisciplinary team provides an innovative manufacturing platform that enables the production of these ‘living treatments’ at scale, through automation.
The company has the ambition to grow our team with a proactive approach to excellence and diversity, adding more passion and know-how with every individual we bring on board.
Quality Engineer (F/M, 80-100%)
LOCATION: Biopôle, Epalinges, Switzerland
START DATE: 1 SEPTEMBER 2024 or later
You want to discover what it is like to work in a fast-paced, mission-driven start-up environment? You have the ambition to contribute to an ambitious project while learning new skills? You are flexible and dedicated, ready to tackle challenges and be rewarded with opportunities? This role is for you!
Position Summary
To support Limula in its mission to make Cell and Gene Therapies accessible to patients, you will support the Chief Operations Officer in the implementation and maintenance of the company quality management system (QMS), and perform and contribute to the quality related tasks during the whole product life cycle.
Required Qualifications:
M.S Degree in business, science or technology.
Minimum 2 years working in quality roles in the life science or medical device industry.
In-depth knowledge of ISO 13485:2016 and/or ISO9001.
Prior experience in implementing and managing a QMS.
Prior experience with new product introductions and/or supplier management and/or manufacturing and/or product development.
Excellent verbal and written communication skills in English.
Preferred Qualifications:
M.S Degree in Biomedical Engineering or related field.
Experience with Project Management and/or working in a start-up environment, ideally in a company developing or supplying Life Science Tools.
Good knowledge of ATMP/GMP regulations, particularly as applied to cell therapy.
Good knowledge of medical device or laboratory equipment standards, e.g. ISO 61010-1/ISO 60601-1.
Good knowledge of the Low Voltage Directive (2001/95/EC).
Good knowledge of FDA 21 CFR 820 QSR (cGMP).
Soft Skills:
Proactive and autonomous.
Strong sense of responsibility.
Attention to details, analytical and structured work, problem-solving skills.
Sustained capacity to meet deadlines and coordinate with others.
Roll up your sleeves" attitude, ability to work in a multidisciplinary, multinational team.
Ability to organise, prioritise, balance risks and handle multiple projects / activities in parallel.
Good communication and influencing skills.
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