Quality Assurance Specialist
Vor 5 Tagen
Limula SA is a Life Science Tools company based in Switzerland, dedicated to making highly personalised cell therapies accessible to patients at reasonable cost. Our mission-driven team provides an innovative manufacturing platform for the production of 'living treatments' at scale, through automation.
We are seeking a proactive Quality Assurance Specialist to support our Chief Operations Officer in implementing and maintaining our quality management system (QMS). The successful candidate will champion a culture of quality across the company, provide guidelines, and train other team members on procedures.
Key Responsibilities:
- Champion 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.
- 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.
Requirements:
- 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.
Benefits:
- Company mission that aims to impact the lives of patients with life-threatening conditions.
- Innovative and multidisciplinary project, at the interface between engineering and biology.
- An opportunity to work in the Cell and Gene Therapy industry, one of the most exciting and fast-growing medical fields.
- Fast-paced, highly stimulating startup environment with a collaborative atmosphere.
- Unique opportunity to join a company at an early stage, with avenues for career development and personal growth.
- Competitive salary, with additional advantages and incentives, including a fully funded pension.
- Respectful and equal opportunity work environment, in a world-class location.
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