Validation Engineer

il y a 4 jours


HautsdeFrance, France elemed Temps plein

🔎 Title: Validation Engineer (freelance)

đź“Ť Location: Hauts-de-France, France (on-site 5 days a week)

✉️ Contact: Veronica@elemed.eu

🔸 The Company

Do you love collaborating with ambitious professionals in a dynamic, purpose-driven environment? This company is leading the way in groundbreaking medical device innovation. With a strong commitment to community and employee happiness, we foster a culture where experts thrive and mentorship is a priority. Our team is passionate about building a healthier future through ethical practices, innovative solutions, and integration across global markets.

🔹 The Opportunity

Are you passionate about quality engineering and ready to take on a meaningful challenge? Here’s your chance to define the standards in a pivotal six-month project aimed at remediation and process validation for critical equipment. You’ll step into an engaging role where you’ll collaborate with an unusual team of co-operating partners to make an impact. This opportunity is not just about ticking boxes—it’s a chance to create something lasting while learning and building your career in an innovative environment.

🔸 Your Responsibilities

Scope: Remediation activities of critical equipment and process validation support

Outcomes:

  • Risk assessment support covering pFMEA activities
  • Support CQA and CPP activities to identify and control key product characteristics
  • Validation strategy and quality planning reviews

🔹 Your Qualifications

  • Proven expertise in ISO 13485, 21 CFR 820, and medical device quality management systems.
  • Deep knowledge of validation processes, including process validation, sterilization, and CE marking.
  • Ability to work on-site full-time and fluency in French is a must.

✉️ If you are interested in this exciting role, please send your application directly to Veronica@elemed.eu .

Please note: Due to the high volume of applications, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.

Key skills we recruit for:

ISO 13485, 21 CFR 820, CE marking, MDR, medical device regulation, MDD, medical devices, digital health, 510(K), PMA, regulatory affairs, quality assurance, QA/RA, design quality, ISO 14971, combination devices, sterilization, AIMDD, CER, PMCF.

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