Career

We are BIOPIX-T, a biotechnology start-up in the field of diagnostics based in the Science and Technology Park of Crete (STEP-C). Our mission is to offer portable diagnostic devices to every potential end-user, regardless of financial status, geographical location and training. We keep growing our capabilities and we’re currently looking for a Quality Assurance Manager.

The Role

As a QA Manager you will work with our Compliance Department to ensure that BIOPIX-T procedures, applicable regulations and standards (regulatory requirements of Medical Devices and/or In Vitro Diagnostics Regulation of the European Union, ISO 13485, etc.) are followed throughout the company lifecycle and across all company products.

Responsibilities of the job include:

You support and enable our operations business partners regarding product care and product improvement activities as well as in all other quality aspects within the area of responsibility.
You ensure product quality and compliance to the regulatory requirements and the proper documentation of all activities.
In your role as quality responsible person, you support our business partners, review and approve changes, deviations and documents to ensure product quality and compliance.
You are the quality responsible person for design transfer or technical product transfer projects to ensure product quality and compliance.
You lead and/or support special projects or initiatives in the area of Quality and business partners.
You constantly optimize processes in order to increase quality and efficiency standards.

Skills

Essential

You have a Bachelor’s or Master’s degree in an Engineering or Life science discipline.
You bring along professional experience in Quality Assurance with the medical device regulations including ISO 13485 and/or IVDR regulations for the above-mentioned processes.
You have experience in process risk analysis and verification of product changes.
You have strong communication skills in both Greek and English.
You are able to lead a process improvement project.
You excel in a demanding interface role within a complex environment and have a solution-oriented mindset as well as good stakeholder management skills across all hierarchy levels.
You describe yourself as self-dependent, structured, quality oriented and determined.
You are a catalyst to the department’s strong team spirit

Desirable

Strong communication and leadership skills
Ability to coach others
Great attention to detail
Excellent organizational abilities
Reliable and trustworthy

On top of an exciting, vibrant and intellectually challenging workplace, we are offering:

Salary range €1600 – € 2100 gross/month (depending on skills and experience)

Flexible working hours, ability to occasionally work from home

Continuous learning and development opportunities

CVs will be screened as they come in and only shortlisted applicants will be notified and given reasonable notice ahead of interview. All shortlisted applicants will be notified of the interview result within maximum 4 weeks’ time after the interview. The role is expected to commence as soon as possible.

BIOPIX DNA TECHNOLOGY P.C. is an equal opportunity employer. We want applicants of diverse background and hire without regard to color, gender, religion, national origin, citizenship, disability, age, sexual orientation, or any other characteristic protected by law.