QA Technician

Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes.Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering withphysicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagship product, SIR-Spheres Y-90 resin microspheres, is a targeted radiation therapy for liver cancer. To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement.At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services tosupport our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients.Job DescriptionThe position QA Technician (m/f/d) is vital in assuring that only product meeting defined quality and regulatory standards leaves the manufacturing location. This position requires a detail oriented individual capable of working well organized and efficiently in a clean room environment and with the demands of production timelines and commitments.PRIMARY RESPONSIBILITIES:Ensure all activities are performed in accordance with Quality System requirements, work instructions and regulatory requirementsAuthorize or prevent release of approved material, intermediates and finished productPerform incoming, in-process and final inspectionsPerform microbiological testing of environment and product as necessaryPropose training in Quality Systems and related processes according to identified needsSupport nonconformance investigations; identify needs for Corrective, Preventive and Improvement actionsOrganize and document reports, files and results in a professional, proficient manner and according to GDP and GMP requirementsSupport internal / external audits / inspectionsWork closely with production team for all quality related topics on siteAdhere to practices designed to protect both employees and product from contact and potential contaminationBe flexible and work within a small team assuring complete functional coverageQualificationsMinimum 3 years previous QA experience working in Quality Control of the medical device or biopharmaceutical industry, laboratory or other highly regulated environmentProfessional Education as CTA, BTA, chemical laboratory technician or biology laboratory technicianPrevious experience handling chemicals and using basic chemical laboratory equipmentHigh profile commitment to Quality principles and ability to administer or work within Quality SystemsUnderstanding of integrity and problem-solving attitudeStrong organization and time management skillsStrong interpersonal skills, energetic, proactive, flexibleBasic office computer skills (email, word processing, and spreadsheet software)Advanced level of German and English (minimum B2)Additional InformationAll your information will be kept confidential according to EEO guidelines.Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people's lives. Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success.Sirtex offers qualified candidates:Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.Attractive compensation and benefit packages which are practical, robust and equitable.A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.An unwavering commitment to company values, employee safety and excellence in everything we do.Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.Sirtex is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.