Main purpose of the job
The Quality Coordinator is accountable for developing the company’s documentation practices, preparing quality assurance and controls, in preparation for a Quality Management System, and conforming to the internal, customer and standard/regulatory/legal requirements.
The Quality Coordinator’s goal is to guarantee that proper documentation and procedures are followed securing products and services to be free from errors. The Quality Coordinator functions essentially as an auditor, working to maintain compliance with company standards and industry regulations, as well as local and national laws.
The Quality Coordinator has a key role in facilitating and coordinating the development of all processes and practices at Biomensio.
Duties and responsibilities
- Establishing and maintaining a meaningful documentation system for early and growth stage operations of the company; securing the documentation practices and developing processes, across all activities including sensor manufacturing and packaging, reader, cartridge, and bioassay development
- Coaching of Biomensio staff in the execution of the above matters
- Understanding customer needs and requirements to develop effective quality control processes
- Initiating, establishing, and strengthening continuous improvement practices and develop best practices with a multidisciplinary team
- Ensuring a synchronized way of working across the company and teams
- Analyzing and resolving quality issues, coordinating the establishment of risk management processes
- Setting up a roadmap for quality and communication system, following-up the plan’s execution
- Understanding of the regulative requirements for Biomensio: coordinating the establishment of quality practices (especially ISO 9001 and ISO 13485); according to company needs
- Development work towards establishing and maintaining a Quality Management System, Quality Manual and Quality Policy of Biomensio
- Helping in R&D work as needed, according to interests and skills
- Leading quality improvement activities
- Participating and contributing to all aspects of the Biomensio team development
Qualifications and skills needed
- A Master’s degree or higher in relevant field
- Conscientious and responsible with a keen eye for detail and a result driven approach
- Outstanding communication skills, fluency in English language, Finnish is an advantage
- Excellent organizational and team working skills
- Prior experience with medical devices and the related quality requirements is considered as an advantage
- Understanding of quality control procedures and relevant regulatory and legal standards
- Working knowledge of qualitative and quantitative analysis methods
- Understanding of the regulative requirements for Biomensio as well as general understanding of quality standards
Interested: please send a CV and cover letter at careers’at’biomensio.com. We are evaluating candidates continuously, so send your application ASAP, but no later than 15th March 2023.
For more information, contact Anna Spehar: anna.spehar’at’biomensio.com or phone: +358 44 2380971
Biomensio is an exciting and highly innovative biotechnology company located in Espoo and Tampere. We develop highly scalable multiplexing Lab-on-a-chip devices that render results quickly on-site. More than ever, the marketplace is driven by the goal of creating diagnostics that can be used by health-care professionals at all skill levels, deliver automated results in minutes and be deployed on site.