Quality Engineer responsible for assuring quality in production across two sites in Germany. Focused on quality planning, supplier management, and process evaluations with a critical technical understanding.
About the role
- Senior Software Quality Engineer supporting Digital Health projects. Involved in software design quality assurance for medical device product development.
Responsibilities
- Designed and tested prototypes and components.
- Conducted root-cause analysis and problem-solving.
- Translated design inputs into engineering specifications.
- Developed software components and led code reviews.
- Collaborated cross-functionally with R&D, Quality, Regulatory, and Marketing teams.
Requirements
- Bachelor’s degree in a science or engineering.
- Minimum of 2+ years of experience working in a highly regulated industry in following cGMP and GDP regulations.
- Experience working through software lifecycle processes (Agile SAFe/Waterfall).
- Experience with software Failure Modes Effect Analysis (sFMEA).
- Proven ability to influence design quality across global, multidisciplinary teams.
- Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations.
Benefits
- Eligible for bonus
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
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