7 days ago
Helsinki, FinlandMid Level / Senior
Responsibilities
- Develop, implement, and manage QMS processes for compliance.
- Support continuous improvement of the QMS by identifying areas for enhancement.
- Investigate complaints and manage Corrective and Preventive Actions (CAPAs).
- Lead the configuration and optimization of the eQMS toolset.
- Deliver training programs on quality requirements and best practices.
- Manage supplier control processes to ensure compliance with quality benchmarks.
- Collaborate with SaMD feature development teams for quality support.
- Contribute to the compilation and approval of technical documentation.
- Support internal and external audits as a QMS expert.
Requirements
- Degree in Biomedical/Mechanical Engineering or related field.
- 3+ years of experience in a regulated environment managing QMS.
- Knowledge of device regulations (21 CFR 820 and EU MDR 2017/745).
- Strong background in standards compliance (ISO 13485:2016, ISO 14971, IEC 62304, IEC 62366-1).
- Familiarity with eQMS software and digital quality workflows.
- Experience with regulatory inspections and quality audits.
- Ability to assess and provide guidance for software as a medical device.
- Strong organizational and prioritization skills.
- Detail-oriented with leadership and communication skills.
Benefits
- Competitive Salary
- Lunch benefit
- Wellness benefit
- Flexible working hours
- Collaborative, smart teammates
- An Oura ring of your own
- Personal learning & development program
- Wellness Time Off