Quality Assurance Specialist

Vor 5 Tagen


Lausanne, Waadt, Schweiz Limula Vollzeit
Join Limula's Team as a Quality Assurance Specialist

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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