Quality / Regulatory Specialist

OPTI Medical Systems, Inc. (Montpellier, France) Publié il y a 18 heures

As a Quality/Regulatory Specialist based in our laboratory in Montpellier, you will perform a variety of duties involving critical thinking, analysis, evaluation, and judgment in support of department activities.

OPTI Medical Systems, a subsidiary of IDEXX Laboratories, Inc., is an international and fast-growing diagnostics business with operations mainly in Atlanta, Georgia, USA but also in Europe, serving the high-growth, near-patient testing market, targeting small- to medium-sized hospitals.

Exceeding customer expectations is one of our guiding principles at IDEXX. Our credibility as a company relies on our ability to deliver quality products to our customers on time and with no disruption to their business. IDEXX’s Worldwide Operations Team works to meet this challenge each day with a global network of distribution hubs and a focus on efficiency, regulatory compliance, and continuous improvement.  

In this role:

  • Your main goal will be to support our lab transition between the ISO 9001 standard to the ISO 13485 as well as leading projects, monitoring activities, and evaluating quality opportunities.
  • You will collaborate with team to understand product changes and QA testing requirements to deal with issues/defects in a timely manner.
  • You will review product change which may impact existing or ongoing registrations and product supply.
  • You will create written documentation and procedures for application testing and compliance.
  • You will escalate regulatory compliance gaps and potential patient safety issues to the management and international manufacturing sites.

What you will need to succeed:

  • Bachelors’ degree in Biomedical / Life Science or any related field required.
  • You’ll also have practical working experience of ISO accreditation as well as quality management, within a clinical or veterinary laboratory would be a plus.
  • Knowledge or experience with in vitro diagnostic would be an advantage.
  • You have strong communication skills and ability to influence across groups.
  • Fluent in both French and English
  • You are comfortable working in a cross-cultural work environment.
  • You are flexible and able to adapt to a fast paced, high volume, innovative work environment.

Why IDEXX?

We’re proud of the work we do because our work matters. An innovation leader in every industry we serve, we follow our Purpose and Guiding Principles to help pet owners worldwide keep their companion animals healthy and happy, to ensure safe drinking water for billions, and to help farmers protect livestock and poultry from diseases. We have customers in over 175 countries and a global workforce of over 9,000 talented people.

So, what does that mean for you? We enrich the livelihoods of our employees with a positive and respectful work culture that embraces challenges and encourages learning and discovery.   At IDEXX, you will be supported by competitive compensation, incentives, and benefits while enjoying purposeful work that drives improvement. 

Let’s pursue what matters together!

IDEXX values a diverse workforce and workplace and strongly encourages women, people of color, LGBTQ+ individuals, people with disabilities, members of ethnic minorities, foreign-born residents, and veterans to apply.

IDEXX is an equal opportunity employer. Applicants will not be discriminated against because of race, color, creed, sex, sexual orientation, gender identity or expression, age, religion, national origin, citizenship status, disability, ancestry, marital status, veteran status, medical condition, or any protected category prohibited by local, state, or federal laws.

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