Umea, SWE
25 days ago
Audit Leader
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Audit leader is responsible for planning and realization of internal and external (customer) audits at Umeå site. You will drive improvements based on audit outcomes and track and support implementation on actions. This position reports to the Umeå QA Director and is part of the Quality team located in Umeå, Sweden and will be an on-site role. What you will do: + Facilitate Customer Audits – in-person or paper based - depending on customer requests. + Manage internal audit program - Plan and perform internal audits together with other internal auditors. + Responsible for training other internal auditors on site and maintaining a good collaboration to learn from each other within the internal auditor team. + Collaborating with global audit team. + Secure timely implementation on actions resulting from audits. Who you are: + Bachelor’s degree or working experience in Quality Assurance or 4 years working experience in hardware/pharmaceutical industry. + Excellent oral communication and reporting skills in Swedish and English. + Excellent business correspondence and procedure-writing skills in Swedish and English. + Valid work permit It would be a plus if you also possess previous experience in: + Hosting audits + Customer communication + Knowledge of industry standards and regulations (e.g., ISO 9001, GMP) To excel in this role, we believe you should have a quality-focused mindset, enjoy collaborating both within your function and cross-functionally, be comfortable interacting with customers, and possess the ability to build trust. Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At HemoCue, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. HemoCue is a leading provider of point-of-care diagnostic solutions, enabling healthcare practitioners across clinical settings and geographies to improve patient outcomes and clinical workflows. For more than four decades we’ve been advancing what’s possible at the point of care. HemoCue offers point-of-care testing for hemoglobin, glucose and HbA1c as well as total and differential white blood cell count. Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. HemoCue R&D is expanding its capabilities and is now seeking a skilled and motivated Test Engineer to join our System Verification and Validation team. As a Laboratory Test Engineer , you will be instrumental in advancing point-of-care diagnostics by designing, planning, and conducting a variety of laboratory tests, as well as evaluating and documenting the results. Additionally, you will oversee analytical methods and manage lab equipment within our R&D department. This is a full-time, on-site position based in Ängelholm, where you’ll be part of a collaborative and forward-thinking team of test engineers, specialists, and researchers. You will report to the Manager of Clinical Operations. In this role, you will have the opportunity to: + Plan, perform, and evaluate formal verification tests in collaboration with the system verification test leader + Support R&D projects by planning, executing, and analyzing various types of laboratory testing + Contribute to the development and refinement of new test methods + Take ownership of the sustainment and qualification of laboratory equipment + Ensure all work complies with ISO 13485, QSR, and Design Control standards The essential requirements of the job include: + A university degree (BMA, B.Sc, or M.Sc) in natural sciences or engineering + Hands-on experience in laboratory work (chemistry, biochemistry, BMA) + Proven ability to plan and evaluate laboratory tests + A solid understanding of statistics + Fluency in Swedish and English - written and verbal It would be a plus if you also possess previous experience in: + Experience performing system verification testing + Background in medical device product development As a person you’re a structured, efficient, and solution-oriented team player who thrives in a fast-paced environment. You enjoy tackling new challenges, communicating effectively with colleagues, and contributing to a culture of continuous improvement—both in processes and technology. While Swedish will be your primary language for daily communication, fluency in English—both written and spoken—is essential. The recruitment process for the advertised position is planned to begin in mid-August, taking summer vacations into account. Please note that the position may still be closed earlier if we identify a suitable candidate before then. We appreciate your patience and wish you a wonderful summer! #LI-Onsite #LI-AH1 Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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