Head of Quality Control (M/F)
Job description

Join one of the most promising company in the Swiss Medtech environment

Abionic is committed to revolutionize the world of in vitro diagnostics with rapid universal point-of-care solutions, based on disruptive technology. Abionic offers the world of healthcare a novel point-of-care diagnostic tool and thereby fills patient’s unmet needs.

Abionic is a fast-growing company with ambitious objectives, a spin-off from EPFL and a proud member of Health Valley, located in the Lausanne area, Switzerland.

We are looking for our Head of Quality Control to complete our team.

Your Tasks

We are looking for an experienced Head of Quality Control 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 for activities related to the manufacturing of IVD kits as well as QC methods development. You will report directly to the COO and collaborate closely with our Head of Production, our Industrialization Manager and our Head of Assay Development.

Your main tasks will be to:

·        Lead the Quality Control Team: 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 on 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.

·        Implement and follow-up KPIs within your scope of responsibility in order to take data driven actions on quality issues with a preventive approach.

·        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 Record files are timely recorded 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 need 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 5 years of relevant professional experience in Quality Control 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.

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

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

·        Rigor, attention to details and sense of responsibility.

·        Agile and able 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: 100% (80% to be discussed)

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

Type of contract
100% (80% to be discussed)