Quality engineer
About this role
*Your Role**
In this role, you will be responsible for maintaining and developing our Quality Management System (QMS) and supporting product release activities. You will ensure that quality documentation and records management processes comply with applicable regulatory requirements and industry standards. In addition, you will support internal and external audits and contribute to the continuous improvement of quality processes.
*Key Responsibilities**
Maintain and develop the Quality Management System (QMS) in accordance with regulatory requirements and industry standards
Maintain Device Master Records (DMR) and ensure documentation accuracy and completeness
Support QA release activities, including reviewing and organizing release documentation
Manage document control, ensuring accurate versioning and timely routing of procedures, forms, and records
Coordinate internal audit programs and follow up on audit findings and corrective actions.
Support deviation management and CAPA processes
Compile and monitor quality metrics, dashboards, and management reports
Contribute to process improvement initiatives and quality-related projects
Contribute to external audits and regulatory inspections
*What We Expect From You**
Bachelors or Masters degree in Engineering or another relevant field
Experience in quality assurance within the medical device industry or another regulated environment
Experience working in a manufacturing environment and with production quality activities, product release processes, and manufacturing documentation
Good understanding of ISO 13485, FDA 21 CFR Part 820, and related regulatory requirements
Experience with Quality Management Systems and document control processes
Experience working with ERP and/or eQMS systems is considered an advantage
Strong analytical thinking and problem-solving skills
Good communication and collaboration skills in both Finnish and English
Good documentation and technical writing
Responsibilities
- *Your Role**
- *Key Responsibilities**
- Maintain and develop the Quality Management System (QMS) in accordance with regulatory requirements and industry standards
- Maintain Device Master Records (DMR) and ensure documentation accuracy and completeness
- Support QA release activities, including reviewing and organizing release documentation
- Manage document control, ensuring accurate versioning and timely routing of procedures, forms, and records
- Coordinate internal audit programs and follow up on audit findings and corrective actions.
- Support deviation management and CAPA processes
- Compile and monitor quality metrics, dashboards, and management reports
- Contribute to process improvement initiatives and quality-related projects
- Contribute to external audits and regulatory inspections
Requirements
- *What We Expect From You**
- Bachelors or Masters degree in Engineering or another relevant field
- Experience in quality assurance within the medical device industry or another regulated environment
- Experience working in a manufacturing environment and with production quality activities, product release processes, and manufacturing documentation
- Good understanding of ISO 13485, FDA 21 CFR Part 820, and related regulatory requirements
- Experience with Quality Management Systems and document control processes
- Experience working with ERP and/or eQMS systems is considered an advantage
- Strong analytical thinking and problem-solving skills
- Good communication and collaboration skills in both Finnish and English
- Good documentation and technical writing