Adress
ArbetsformThe conviction that “it must be possible” has been the driving force behind HemoCue for over 40 years, because when it comes to caring for people, we refuse to compromise. We take pride in being a global leader in near-patient, or point‐of‐care, testing where the patient meets the healthcare system for the first time and where accurate, reliable, and fast decisions need to be made. Our culture of positivity, engagement, and a dedication to getting it right will allow you to achieve something remarkable. Join a team where making the impossible possible has become the standard!
HemoCue is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The Manager QA Operations for HemoCue is overall responsible for the quality assurance related activities and support to the Supply Chain as well as to Supplier Management.
This position is part of the Regulatory Affairs and Quality Assurance (RAQA) department. The position is located at the headquarter in Ängelholm, Sweden and can be held on-site or in a hybrid setup. At HemoCue, our vision is to do things easier, to do things better, and to do them right.
You will be a part of the leadership team of the RAQA department and report to the Senior Director RAQA responsible for establishing, implementing and maintaining the Quality Management System in accordance with applicable regulations and standards. RAQA is responsible for quality assurance of the Supply Chain and Regulatory and Design Quality meaning assurance of the product quality during design and development, internal as well as external audits, Corrective and Preventive Actions, product registrations, data privacy, complaints and vigilance reporting. If you thrive in a truly cross-functional fast paced supporting leadership role and want to work to build a world-class Quality Assurance organization—read on.
In this role, you will have the opportunity to:
- Lead, mentor and rigorously develop talent within the QA Operations team
- Continuous improve quality management system processes
- Being responsible for supplier audit program and support organization in supplier qualifications
- Support Supply Chain organization in the daily operations with e.g general improvements, nonconformance handling and process validations.
The essential requirements of the job include:
- University degree in Science or Technology
- Knowledge of applicable standards and regulations including but not limited to IVDR/IVDD, ISO 13485, US Quality System Regulations for Medical Devices, and risk management for medical devices (ISO 14971)
- Minimum 5 years’ experience in a Quality and Regulatory role within the industry field
- Minimum 3 years of management experience or other leadership roles
- Business level English communication skills
It would be a plus if you also possess previous experience in:
- Being lead internal and/or supplier auditor
As a person you are business and results oriented, creative with strong analytical skills. You find it easy to communicate with other people and enjoy working in a company that is driven by continuous improvement, both in terms of equipment and processes.
Last day of application is January 8th and recruitment. Welcome in with your application!
For any questions regarding the role, please connect with hiring manager Maria Fagerberg,
Contact details to Union Representative:
För Akademikerföreningen: Katarina Cooper, tel
För Unionen: Björn Bylander, tel
At HemoCue we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for HemoCue can provide.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization. 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. If you’ve ever wondered what’s within you, there’s no better time to find out.
