Job
- Level
- Experienced
- Job Field
- Test/QA
- Employment Type
- Part Time/Full Time
- Contract Type
- Permanent employment
- Location
- Lübeck
- Working Model
- Hybrid, Onsite
Job Technologies
Your role in the team
You will complement and support our customers' development teams in all areas relevant to the conformity assessment of medical devices and regulatory issues.
Your main areas of activity will be:
- Preparation of risk analyses
- Creation of verification and validation plans
- Documentation according to CFR820 or DIN EN ISO 13485
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Our expectations of you
Education
- a completed engineering degree or a comparable qualification
Qualifications
The ideal candidate has:
- a strong technical understanding
- good knowledge of ISO 13485, IEC 62304
- Knowledge of ISO 14971, FDA QSR 820, IEC 80001, IEC 80002,
- Knowledge of process management, document control, version control and change management
- a structured and independent way of working
- Independence
- Teamwork
- fluent English skills
- Willingness to travel / mobility
- confident appearance
Experience
- several years of professional experience in medical technology
- Experience in dealing with Notified Bodies and/or the FDA
- Audit experience
- Experience in project management
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Benefits
Work-Life-Integration
Topics that you deal with on the job
Job Locations
This is your employer
Qtec Services Gmbh
Qtec Services GmbH specializes in supporting medical device manufacturers in regulatory affairs and quality management. With a wide range of services, the company accompanies the entire lifecycle of medical devices.
Description
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Healthcare, Social Sector
Software Quality Manager
- Location
- Lübeck
- Working Model
- Hybrid, Onsite
- Diversity
- Open for all genders
