Quality Control Manager (M/F)
Job description

We are looking for a Quality Control Manager to complete our team!

 

Your Tasks

In this key position, you are responsible for the Company’s Quality Control Team comprising a Quality Engineer and two Laboratory Technicians. You will report directly to the Chief Operations Officer and work in close contact with the Production Managers and the Chief Scientific and Technology Officers to develop, validate and implement new quality methods. The tasks associated to this position are:

  • Lead the Quality Control Team and manage/plan activities to control the quality of materials and products (incoming inspections, in-process controls and final controls for batch release) ensuring a close partnership with Production.

  • Perform statistical analysis to analyze trends, determine assay validity and acceptance criteria for Quality Control methods and procedures.

  • Review test results, write technical reports, and support documentation of CAPAs, deviations and non-conformities.

  • Develop and/or modify existing methods and procedures to verify that materials and products meet specified requirements.

  • Work closely with Production to investigate, conduct root cause analysis, recommend corrective actions for processes and products.

  • Provide support in reviewing, drafting and revisioning of operational procedures concerning Quality Control tests.

  • Represent Quality Control in meetings to understand production and test development needs and priorities and provide analytical information and expertise.

  • Provide support to Production and Test Development Teams to ensure compliance with specifications and facilitate transfer of new products from Development to Manufacturing.

 

Your Skills

  • Degree in Life Sciences (or related) with 5+ years (M.Sc.) or 2+ years (Ph.D.) of relevant professional experience in quality control, ideally in the IVD industry or the medical device industry. Experience in direct supervisory responsibilities is mandatory.

  • Practical knowledge of the ISO 13485 standard and of the EU 98/79/EC (IVDD) and/or the 93/42/EEC (MDD) is required. Knowledge of the US FDA CFR 21 Part 820 is a plus.

  • Strong bioanalytical and protein biochemistry skills are needed. Practical experience with development and validation of immunoassays is a plus.

  • Ability to perform work independently and in a team in a fast-paced environment.

  • Ability to prioritize, manage multiple tasks with agility and deliver timely results.

  • Excellent oral and verbal communication skills, mastery of technical writing.

  • Attention to details, methodical and meticulous in approaching problems, data-driven with high commitment to quality.

  • Fluent orally in English and/or French. English written fluency is mandatory.

  • Basic computer skills (Windows, MS-office)

She/He must be motivated to contribute to the development and production of a highly innovative diagnostic platform as part of our young, talented and ambitious team.  

 

We Offer

A challenging job within an exciting modern environment within a Medtech company,

Integration in a dynamic and growing team,

A highly innovative environment,

An opportunity to improve healthcare.

 

Key Information

Starting date: Immediately

Activity rate: 80-100%

You want to work in a modern environment and to integrate a dynamic team? Please send us your application (CV, cover letter, and work certificates when applicable) to marc.flotron@abionic.com, indicating “QC Manager position” in the e-mail subject. Marc is also your contact person for all questions regarding this position.

Type of contract
Permanent
Start
Location
Epalinges