Quality Assurance

il y a 2 jours

Paris, France Science Temps plein

Science is a clinical stage, vertically integrated technology company focused on solving some of neuroscience's hardest questions and most serious unmet medical needs. We work to restore quality of life to those with debilitating conditions for which there are no treatment options, creating devices aimed at restoring vision, cognition, and mobility to patients who have lost it. To support progress across our industry, we provide state-of-the-art components and vertically integrated infrastructure for others to build on via Science Foundry.

In this role, the QARA Lead will supervise and assure compliance of products, processes and operations with the applicable regulations, standards and quality system. This includes managing regulatory compliance processes and ensuring that products meet legal and safety requirements as well as communication with regulatory authorities and IRBs or ethiccommittees.

**Role responsibilities**:

- Ensure compliance throughout the site by preparing and reviewing quality system documents, actively participating in the design control process, including design reviews, compliance audits, ensuring subcontract regulatory requirements are met, being aware of future regulations and taking proactive measures, and ensuring appropriate understanding of regulatory requirements throughout the company.
- Propose and execute the regulatory approval pathways, including preparation and management of all regulatory submissions. Communicate with regulatory authorities.
- Maintain and manage the QMS and report to management on the effectiveness of the QMS, including any need for improvement.
- Serve as the person responsible for regulatory compliance (PRRC) under MDR 2017/745, inclusive of the performing the duties expected of the PRRC under MDR 2017/745.

**Required qualifications**:

- Engineering degree or equivalent.
- At least ten years of quality and regulatory experience in the medical device industry.
- Thorough understanding of quality systems (MDR 2017/745, ISO 13485, 21 CFR 820) and risk management (ISO 14971).
- A proven track record of successful leadership in implementing a pragmatic quality assurance program.
- Able to interpret and understand complicated processes and their documentation needs.
- Able to think analytically and good problem solving skills.
- Fluent in English and French.
- Disciplined and well organized.

**Preferred qualifications**:

- Experience obtaining CE mark.
- Experience in ISO certification.
- Experience in implantable medical devices.
- Experience in a start-up environment

Science Corporation is an equal opportunity employer. We strive to create a supportive and inclusive workplace where contributions are valued and celebrated, and our employees thrive by being themselves and are inspired to do their best work.

We seek applicants of all backgrounds and identities, across race, color, ethnicity, national origin or ancestry, citizenship, religion, sex, sexual orientation, gender identity or expression, veteran status, marital status, pregnancy or parental status, or disability. Applicants will not be discriminated against based on these or other protected categories or social identities. Science will also consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state and local law.

  • Quality Assurance Associate

    il y a 2 semaines

    Paris, France RPMGlobal Temps plein

    **Quality Assurance Associate - 12 month contract** - Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases._ **Position Summary** The Quality Assurance Associate will be involved in a wide range of activities related...

  • RESPONSABLE QUALITY ASSURANCE

    il y a 4 semaines

    Paris, France Carte Blanche Partenaires Temps plein

    RESPONSABLE QUALITY ASSURANCE H/F - CDIPoste ouvert aux personnes en situation de handicapExpert en services santé, Carte Blanche Partenaires a pour objectif d’accompagner plus de 12 millions de bénéficiaires en leur permettant d’accéder à des équipements et à des soins de qualité au juste prix, ainsi qu’à des programmes de prévention en...

  • Quality Assurance Specialist

    il y a 1 semaine

    Paris, France Skills Alliance Temps plein

    Consultant | Medical Devices | QARA | United States & Europe🔭 🚀 Quality System Specialist / Complaint Handling and Document Control I am supporting a fast growing French medtech company developing an innovative solution designed to improve postoperative recovery in digestive surgery. Their technology aims to reduce the need for traditional stomas,...

  • Quality Assurance Engineer

    il y a 2 jours

    Paris, Île-de-France Ceva Sante Animale Temps plein

    Quality Assurance EngineerThe success of a company depends on the passionate people we partner with.Together, let's share our talents.As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes...

  • Quality Assurance Engineer

    il y a 2 semaines

    Paris, France Therapxiel Temps plein

    **Quality Assurance Engineer** **Therapixel - a leading software company specializing in Artificial Intelligence applied to medical imaging.** Our goal is to provide radiologists with innovative software, designed with a high level of safety, quality, and performance, to help them improve their clinical practice. We are a multicultural, dynamic, and...

  • System Quality Assurance Manager

    il y a 5 jours

    Paris, France PathoQuest Temps plein

    **Who We Are**: PathoQuest is a specialized CRO, a spin-off of Institut Pasteur, whose purpose is to study, research and identify pathogens by High Throughput Sequencing for the Quality Control of pharmaceutical products of biological origin, both in France and abroad. PathoQuest offers innovative biotech companies worldwide a complete expert service from...

  • Associate Quality Assurance Manager

    il y a 11 heures

    Paris, France Mundipharma Temps plein

    Associate Quality Assurance Manager Location: Paris, France Department: Quality Assurance Job type: Permanent Join us and make a difference when it matters most! At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our...

  • Data Quality Specialist

    il y a 1 semaine

    Paris, France L'olivier Assurance Temps plein

    **About**: Would you like to work in a dynamic, international, technological environment, helping build something great from the ground up?**Job Description**: The Data Quality Specialist is responsible for building trust in data, not only for our colleagues in the EU Data Domain but also for our wider business stakeholders. Without good data quality, many...

  • Quality Assurance Analyst

    il y a 9 heures

    Paris, France Adevinta Temps plein

    We’re Adevinta, a global leader in digital marketplaces. Our household name brands, including Marktplaats in the Netherlands, mobile.de in Germany and leboncoin in France, reach hundreds of millions of people every month. We’re all about matchmaking, and our sites help people find whatever they’re looking for in their local communities - whether...

  • Quality Assurance Assistant

    il y a 8 heures

    Paris 8e, France DKT Woman Care Global Temps plein

    **Job Title** Quality Assurance Assistant (Apprentice) **Department** Quality Assurance **Contract type** Apprenticeship **Workplace** Paris, France **Length of Contract** 12 months **Company Description** **DKT International **is a global non-profit organization based in Washington DC and is one of the largest providers of **family planning**,...