Quality and Compliance Manager, Software
PerkinElmer, Wallac Oy
PerkinElmer is currently looking for
QUALITY AND COMPLIANCE MANAGER, SOFTWARE
Turku, Finland (Europe) / Quality
The Turku Site, with 650 employees, represents one of PerkinElmer’s major manufacturing and product development sites for newborn and maternal fetal health screening. As the global market leader in newborn screening, our solutions have tested over 560 million babies worldwide for life-threatening diseases.
We are now looking for an experienced Quality and Compliance Manager to carry responsibility of the overall quality and compliance of medical device software as a services (SaaS) business. The position will be located preferably in Turku, Finland, but other European locations can be considered as well.
- Assess and define appropriate service/product classification together with relevant stakeholders
- Guide practical implementation of relevant regulations, such as ISO 13485, 27001, IEC62304, IVDR/MDR.
- Create required processes and monitor their performance over time
- Guide development and operation teams to integrate the required controls to their processes
- Guide product teams to create and maintain up-to-date risk assessments
- Ensure appropriate level of documentation, verification and validation activities based on the risk assessment
- Drive automation of quality and compliance processes to enable quick release cycles
- Engage with customers to address their compliance needs and concerns
- Conduct and host 3rd party compliance audits as needed
- Participate in sales process as a quality/compliance SME
- Bachelor of science (Computer Science and/or Science-based) degree or higher
- 1 – 2 years of experience working in sustainable Quality System
- Experience on high-volume, scalable enterprise software
- Experience in quality management and compliance in health data regulated environment (eg. 13485, 27001, IVDR/MDR) especially within cloud software context
- Sound understanding of all operational aspects of the software development life cycle – from product management to product development, testing, release and post implementation support; methodologies and best practices
- Good written and verbal communication in English, Finnish is in advantage
What we offer:
- Purposeful & inspirational environment
- Dynamic culture in which customers are at the forefront
- Being part of a highly qualified team that is committed to excellence
- Access to cutting-edge expertise through which you can make positive impact in the world around us
PerkinElmer Turku Site is a drug free site and a medical examination for new employees includes a drug test.
Please apply as soon as possible through the link above. For further information, please contact Katja Vaahtera, Director, Global Quality R&D, +358 400 576 704, preferably on Monday, February 15th between 15 – 16 EET, or on Monday, February 22nd between 10 – 11 EET. Join us today!