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EnsoDataQuality Assurance Engineer
QA Engineer developing E2E automation framework for web and mobile applications in healthcare. Ensuring quality and regulatory compliance in a hybrid work environment.
About the role
- Represent quality assurance in all development project teams and ensure that the product under development complies with relevant development processes (i.e., design control, risk management, human factors engineering) as well as applicable technical standards and regulations
- Review and approve all DHF-relevant documentation produced throughout the design, development and product lifecycle
- Lead and support project teams in applying best practices in document management (GDP)
- Provide quality assurance, oversight and consultancy for all technical, risk management and human-factors activities during development projects, i.e., potentially from early scoping/feasibility through development to design transfer and industrialization
- Support quality-related (assurance) aspects of innovation projects both internally and with external customers and development partners
- Establish and maintain interfaces with quality management units in production/operations, such as manufacturing engineering for process validation and quality control for validation and execution of test procedures
- Support the implementation of development-relevant Quality by Design concepts (control strategy)
- Coordinate and support the implementation of internal Service Level Agreements
- Lead and oversee change and deviation management during development and beyond
- Participate in the change control process by approving change plans and handling change actions within Quality Assurance
- Independently lead and/or participate in design reviews related to the development of new products and ongoing technical activities.
Requirements
- University degree (Diploma, Master’s or Bachelor’s) in engineering, biomedical engineering, mechanical engineering, biochemistry or a comparable field
- At least 5 years of professional experience in quality management for medical devices or in the pharmaceutical industry
- At least 5 years of professional experience in R&D projects and in the design control process
- Solid, practical knowledge of the relevant standards and regulations: ISO 13485 (quality management for medical devices), ISO 14971 (risk management), IEC 62366 (usability engineering – desirable), MDR/IVDR and CFR 820.30
- Practical experience in medical device lifecycle management
- Strong communication skills, analytical thinking and a structured working style
- Fluent German and English, both written and spoken
- Confident user of MS Office
Benefits
- A secure and responsible position within a successful team
- A welcoming culture and structured onboarding
- A friendly working atmosphere and colleagues who treat you as equals
- Idea management, freedom to help shape processes and independent working
- Active support for your professional and personal development through internal and external training opportunities
- Flexible working models and the option to work remotely (up to 2 days per week)
- Company events, free parking and more
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
WA
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