Head of QC/QA, IVD Assay Manufacturing (M/F)
Job description

Your Tasks

We are looking for an Experienced Head of Quality Control and Quality Assurance who is motivated to bring his/her expertise and experience to our company. In this key position, your role will be to lead the Quality Control Team, IVD Assay Manufacturing and take a leading role in the Quality Assurance for activities related to the development and manufacturing of IVD kits. You will report directly to the Scientific Director and collaborate very closely with our Head of Production, IVD Assay, our NPI Manager and our Head of R&D, IVD Assay.

Your main tasks will be to:

  • Lead the Quality Control Team of the IVD Assay Manufacturing Department: you are responsible to ensure that the quality control activities of incoming material and produced goods are realized in due time and in full compliance with the company procedures. You also prepare the Team to follow future demands in manufacturing activities by implementing and supervising the development of novel quality control methodologies and/or modification of existing ones.

  •  Take decision regarding the release of manufactured goods and initiate, plan and lead investigations of non-conforming products. You also participate in the implementation of corrective and preventive actions, in collaboration with the other Teams.

  •  Track product lot specifications to identify drifts and shifts and develop, together with Production, preventive or corrective actions to correct problems and/or improve processes.

  •  Develop novel methods to determine product specifications and control the compliance with targeted specifications.

  •  Participate in Design Review meetings, provide risk assessment expertise and ensure that Abionic Device Master Files are timely assembled and maintained up-to-date, according the Company’s QMS.

  • Monitor compliance with company policies and procedures within the Department and develop and execute organizational and operational policies to accommodate the growth of the Company and its needs to comply to novel quality and regulatory standards. In particular, you support the transition of Abionic to the novel European IVD Regulation.

  • Perform internal audits and prepare reports, including propositions for corrective actions where needed, for Senior Management

  • Support preparation and participate in external audits, as well as auditing of key suppliers. Prepare and ensure timely completion of corrective action plans.

Your Skills:

  • Education in Life Sciences with at least 8+ of relevant professional experience in Quality Control and Quality Assurance in the IVD and/or Medical Device industries. Advanced degree preferred.

  • Strong leadership and a proven experience in managing people and multiple project concomitantly. Excellent capacity to interact with various partners, within the company and externally.

  • Previous professional experience in an ISO 13485-certified environment. Good understanding of FDA CFR Part 830 is a plus.

  • Good knowledge of bioanalytical methods commonly used in the quality control of biomolecules, in particular of ligand binding assays.

  • Rigor, attention to details, dedication and sense of responsibilities.

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

  • Good computer skills (Windows, MS-office).

  • Language requirement: Fluent verbal and written English, knowledge of French is a plus.

She or he must be motivated to contribute to the development of a highly innovative company as part of our young, talented and ambitious team.

We Offer

  •  A challenging job in an exciting and fast-growing company,

  •  Integration in a dynamic team,

  •  A highly innovative environment,

  •  An opportunity to improve healthcare globally.

Key Information

  • Starting date: Immediately.

  • Activity rate: 80-100% (To be discussed)

Please send us your application (CV and a motivation letter) to jobs@abionic.com, mentioning “QC/QA Manager position” in the headline.


Type of contract