Quality Engineer (80-100%)
Limula SA is a Life Science Tools company based in Lausanne, Switzerland. Our mission is to make highly personalised cell therapies accessible to 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.
We have 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.
About This Role
This role is for you if you want to discover what it's like to work in a fast-paced, mission-driven start-up environment, contribute to an ambitious project while learning new skills, and tackle challenges with opportunities.
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).
* Perform and contribute to quality-related tasks during the whole product life cycle.
Main Responsibilities
You will be responsible for:
* Championing a culture of quality: promote a culture of quality across the company, provide guidelines, and train other team members on procedures.
* QMS implementation: lead the development of SOPs and related templates.
* Product Development: lead development, review, and approval of documentation related to new product introduction and support the Limula team in their adoption.
* V&V, Process & SW-validation Supplier Quality Management: support the Limula team with supplier qualification, continuous monitoring and evaluation, including supplier audits.
* Quality Controls and product release: support Limula with the quality controls activities e.g. Incoming goods and final product inspection (IQC & FQC) and product release.
* Risk Management: support the team with product risk analysis, dFMEA and pFMEA.
* Internal Audit: establish and perform an internal audit program.
* Equipment Management: manage the calibration and maintenance of all Limula equipment.
* CAPA and NC: manage product non-conformities, corrective and preventive actions, including those from suppliers.
* Establish complaints procedures of Limula products.
Requirements
To be successful in this role, you should have:
* A 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 ISO 9001.
* 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
The following qualifications are preferred:
* 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
We're looking for someone with:
1. A proactive and autonomous approach.
2. A strong sense of responsibility.
3. Attention to details, analytical and structured work, problem-solving skills.
4. Sustained capacity to meet deadlines and coordinate with others.
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