Quality Assurance Manager (H/F) - CDI
Stilla Technologies

Stilla Technologies

Quality Assurance Manager (H/F) - CDI

  • CDI 
  • Villejuif
  • Bac +5 / Master
  • > 3 ans

L'entreprise

Stilla Technologies

Stilla Technologies

  • Pharmaceutique / Biotechnologique, Santé
  • Entre 50 et 250 salariés

Le poste

Quality Assurance Manager (H/F) - CDI

  • CDI 
  • Villejuif
  • Bac +5 / Master
  • > 3 ans

Who are they?

Stilla Technologies is a Life sciences company whose mission is to improve health by offering researchers and clinicians worldwide solutions for high precision genetic analysis.

Since 2016, Stilla Technologies has empowered researchers with the naica® system, a solution that enables to detect & quantify nucleic acid with unprecedented precision.

The naica® system supports a wide range of genetic tests and molecular biology assays — including liquid biopsy tests for cancer diagnostics, viral load quantification, GMO detection, etc… Overall, the naica® system superior performances make it a preferred technology for precision medicine research and therapeutic monitoring.

Stilla® advises and supports its customers worldwide with a multidisciplinary team, whose expertise spans from microfluidics and chemistry to molecular biology and computer science. Stilla’s talented and multidisciplinary team shares a passion for building successful Life Science and Diagnostic products based on deep technological innovations.

Stilla Technologies
Want to know more about Stilla Technologies?Company culture, teams, technical stack, jobs... Let's go for an immersion!
Visit the profile

Job description

The Quality Assurance Manager is responsible for establishing, implementing and maintaining the Quality Management System (QMS) of Stilla Technologies. He or she would also maintain policies, processes, procedures and controls ensuring that performance and quality of products and activities are best in class.

• Work with all departments to ensure the QMS is implemented properly.
• Create quality plans that support the policy and objectives of the company.
• In cooperation with stakeholders, establish and report on measurable quality objectives and ensure the reporting.
• Prepare and manage the management review.
• Provides Quality review and guidance associated with change controls, investigations, protocols/reports, escalations,
project planning and Stilla procedures.
• Facilitate quality improvement efforts that lead to improved customer satisfaction, greater process efficiency and
product quality.
• Participate in or carry out audits and monitor the implementation of defined action plans.
• Manage NC, CAPA in due time and evaluate the efficiency with stakeholders.
• Management of change (evaluation and approval).
• Management of complaints and trend analysis.
• Management of risk analysis.
• Supervise and ensure the update, review, and approval of quality documents.
• Train personnel on QMS procedures and best practices for implementing the QMS.
• Release the finished products.
• Manage QA team.

Preferred experience

  • Master’s degree or equivalent, with previous experience in similar role in Medtech company.
  • Extensive knowledge and application of device quality regulations and standards, including 21 CFR 820, ISO 13485, ISO 14971, 2017/746, ISO 62366.
  • Lead auditor.
  • Experience in supplier management and relations, including quality agreement generation and maintenance.
  • Experience in validation principles.
  • Expert in hazard analysis and application of risk analysis tools such as FMEA, FTA, etc.
  • Expert in Change Control and CAPA applications.
  • Positive attitude, flexibility, proactivity and be able to communicate efficiently with various stakeholders internally and externally.
  • Ability to work in a challenging and moving environment.
  • Ability to independently represent the department in project teams.
  • Strong skills to organize, prioritize, and execute.
  • Solid oral communication and writing skills in an international environment.
  • Fluent in French and English.

Recruitment process

Why join us?
• Build amazing tools for Focused Genomics in a challenging environment
• Join a young and dynamic Life Science company
• Work with a team who shares a passion for building successful Life Science Products based on deep technological innovations.

Location: Villejuif (94 800)

Stilla Technologies

Stilla Technologies

Cette offre vous tente ?

Questions and answers about the offer
  • Ajouter aux favoris
  • Partager sur Twitter
  • Partager sur Facebook
  • Partager sur Linkedin