Junior QA/RA Engineer – 6-month fixed-term contract
PharmaMedTechRegulatory AffairsQuality Assurancecro
Job description
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. Pay range: CHF72,500 - CHF116,180 Placement within the salary range will vary depending on experience, qualifications, geographic location, and internal equity considerations. Job Summary The Junior QA/RA Engineer will support the Quality & Regulatory Affairs team at Bio-Techne’s Tolochenaz site for a 6-month fixed-term assignment starting January 2027. The role will help maintain and improve the Quality Management System in line with ISO 9001, and support regulatory compliance for life-science products under applicable chemical and product regulations. The role requires a good understanding of quality and regulatory principles in a regulated manufacturing environment. The successful candidate will handle day-to-day QMS activities, including non-conformity and CAPA management, document and change control, supplier evaluations. They will also contribute to technical documentation, labelling and product compliance topics such as CLP and safety data sheets, and help collect and report quality data for KPI. This individual will act as a practical point of contact on quality and regulatory questions for internal teams, turning requirements into clear, workable guidance. The role will work closely with Production, Research and Development, Supply Chain and Product Management to ensure timely resolution of quality issues and drive continuous improvement of processes and compliance. Key Responsibilities Support QA/RA team with the Quality Management System (QMS) of the company, to ensure compliance with ISO9001 Being the owner of some QMS processes Assist QA/RA and customer support team in complaint handling Assist the QA/RA team for the follow-up of quality processes (CAPA, KPI, Technical Documentation) Responsible of the technical documentation of some products Support QA/RA Team with Regulatory Affairs activities, to ensure Bio-Techne products meet all necessary regulatory requirements Work regularly with other departments to make sure product development meets quality and regulatory requirements Reporting to the QA/RA Manager on a regular basis Required Qualifications A degree in a Life sciences/Engineering related field and/or a certificate in Quality Assurance and Regulatory Affairs Understanding of quality and regulatory standard. Professional experience with ISO9001 or other QMS norms (ISO13485, …) in life-science environment English: Full professional fluency, French optional Skills At least 1 year of experience with mechanical devices, microfluidic chips and/or chemicals Autonomous and resourceful, able to deliver results with limited supervision Adaptable and comfortable in a fast-changing environment Enjoys working with people across different functions and disciplines Well organised and detail-oriented, able to juggle multiple priorities and meet deadlines Fluent in written and spoken English; French and/or German is a strong plus Proficient in Microsoft Office (Word, Excel, PowerPoint) Bio-Techne is committed to product quality, customer satisfaction, continuous improvement, minimising environmental impacts and conserving natural resources. Environmental and quality management is an integral core value and a 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. If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact hr@bio-techne.com for assistance.
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