QA/RA Specialist (French and German Speaker)

QA/RA Specialist (French and German Speaker)

QA/RA Specialist (French and German Speaker)

Apply locations Rennes, France FR - Massy CH - Remote FR - Remote

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Job Title: QA/RA Specialist (French and German Speaker)

Location: Rennes (on-site)

BIO-TECHNE SAS is the EUROPEAN distribution platform for IVD products of the American company BIO-TECHNE. Import, packaging, shipping and export activities continued with diversification of the product range (Control products, calibrators and laboratory reagent kits).

Bio-Techne Rennes is also the European representative of IVD manufactured by Minneapolis R&D Systems manufacturing sites. It is the European importer of IVD manufactured by the Bio-Techne USA site.

We are seeking a qualified QA/RA specialist with proficiency in German and French.

This role offers the opportunity to relocate to the Rennes area and be part of an international corporation while working in a human-sized site.

Main Responsibilities

• Collect and analyze quality data, write quality procedures and documents. Monitoring of quality indicators.
• Detect and anticipate changes that may occur in a constantly changing technical environment, that may affect the business.
• Ensure regulatory monitoring and deployment for the field of activity related to IVDR Regulation 2017/746.
• Ensure environmental regulatory monitoring and deployment to activities.
• Updating risk analyses.
• Technical files, control of the CE marking and conformity of CE devices placed on the market.
• Participate in quality audits.

Required skills

• Proven experience with ISO 13485, ISO 14001, and IVDR 2017/746 regulations, including regulatory monitoring and audits.
• Native French with fluency in both German and English.
• Highly rigorous, organized, and adaptable to existing quality systems.
• Ability to work effectively both independently and within a team.
• IT Mastery of the Office suite and familiarity with CRM systems.

Bio-Techne is committed to product quality, customer satisfaction, continued improvement, minimizing environmental impacts, and conserving natural resources. Environmental and quality management is an integral core value and vital part of the Bio-Techne culture.

Why Join Bio-Techne:

• We offer competitive wages along with extensive benefits for employees and their families.
• We invest in our employees’ financial futures through retirement programs and an employee stock purchase plan.
• We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.
• We offer an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that build a culture of caring and belonging.
• We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Bio-Techne is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.

About Us

Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services.
Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.