Quality Engineer overseeing quality assurance in electronics manufacturing. Developing control plans and monitoring KPI performance in a collaborative environment.
About the role
- Quality Engineer shaping QMS in R&D at a biotech startup. Ensuring compliance with regulatory standards and leading risk management efforts.
Responsibilities
- Act as the central interface between the R&D department and the company-wide QA division
- Ensure continuous collaboration and alignment on quality-related topics
- Establish, maintain, and continuously improve the QMS framework within the R&D environment
- Ensure ongoing compliance of Clinical Polarizer development with QMS standards
- Administer the QMS tool and manage our internal standards database
- Analyze product defects, complaints, and non-conformities, initiating and tracking corrective actions
- Plan, organize and deliver internal training sessions on quality-related topics
- Plan and execute internal and external audits
- Lead the risk management process for the development of the Polarizer
- Develop and maintain all related risk management documentation
- Support ongoing development activities of the Preclinical Polarizer by providing expert input on QA-related aspects
Requirements
- Degree in engineering, medical technology, computer science, natural sciences, or a comparable field
- Several years of hands-on experience in regulated product development—ideally in pharmacology, medical technology, cosmetics, or laboratory equipment
- 4+ years of professional experience as a Quality Engineer
- Deep familiarity in QMS frameworks relevant to medical or pharma industries (ISO 13485 and/or GMP)
- Confident use of related software tools
- Proven expertise in risk management (e.g., ISO 14971, ISO 12100)
- Practical application of hazard evaluation methods such as FTA, FMEA, Ishikawa, or HAZOP
- Experience with CAPA tools (e.g., 8D reports)
- Certifications in these areas are a strong plus
- Knowledge of the approval process for machines and systems for the US market is an absolute plus
- A well structured, hands-on approach with strong analytical skills and results-orientated way of working
- Fluent in English, with strong written and verbal communication skills
- Comfortable with working in an international and crossfunctional team in a highly dynamic and rapidly developing environment
Benefits
- Attractive compensation package, including a competitive base salary and stock options
- Key role in a highly advanced and fast-growing startup company
- Impactful product promoting better understanding and treatment of cancer
- International team, from over 30 different nationalities
- Positive work environment with open communication and a collaborative mindset
- Onsite work at state-of-the-art facilities with home-office opportunities
- Indefinite employment contract
- 30 vacation days
- Flexible working hours
- Annual health budget (Allianz bKV)
- EGYM Wellpass
- Relocation support
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
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