Quality Engineer (m/f/d)
Quality Engineer (m/f/d)
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Job Description
Your mission
As a key member of our R&D department you will serve as the pivotal link between research and quality ensuring our cutting-edge development work aligns seamlessly with regulatory standards. This role holds significant influence shaping the QMS within our R&D landscape. Youll drive quality from concept through to execution leaving your fingerprint on technologies that transform lives.
Your responsibilities:
- Act as the central interface between the R&D department and the company-wide QA division ensuring continuous collaboration and alignment on quality-related topics
- Establish maintain and continuously improve the QMS framework within the R&D environment in alignment with ISO 13485 / Section 7.3 (Design and Development)
- Ensure ongoing compliance of Clinical Polarizer (Lean Pharma Plan/Device) development with QMS standards by actively monitoring and reviewing development activities.
- Administer the QMS tool and manage our internal standards database
- Analyze product defects complaints and non-conformities initiating and tracking corrective and preventive actions (CAPA) as necessary
- Plan organize and deliver internal training sessions on quality-related topics to promote awareness and compliance across the team
- Plan and execute internal and external audits assist with supplier qualification and monitoring and follow up on audit findings to drive continuous improvement.
- Lead the risk management process for the development of the Polarizer from initial hazard identification through risk analysis evaluation and mitigation. Develop and maintain all related risk management documentation
- Support ongoing development activities of the Preclinical Polarizer by providing expert input on QA-related aspects as needed
Your profile
- Degree in engineering medical technology computer science natural sciences or a comparable field with several years of hands-on experience in regulated product developmentideally in pharmacology medical technology cosmetics or laboratory equipment.
- 4 years of professional experience as a Quality Engineer with deep familiarity in QMS frameworks relevant to medical or pharma industries (ISO 13485 and/or GMP) and confident use of related software tools
- Proven expertise in risk management (e.g. ISO 14971 ISO 12100) and 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 with a willingness to play a key role in shaping the company in your area of responsibility
Why us
- Competitive compensation including base salary and virtual shares
- Onsite work (Ulm) in a modern office/lab environment with home-office opportunities (no relocation necessary)
- Attractive relocation package (if necessary)
- Annual health budget (Allianz bKV)
- 30 vacation days
- Flexible working hours
- Key role in a highly advanced and fast-growing startup company
- Ample opportunity for personal initiatives openness to new ideas and room for considerable personal impact
- Impactful product promoting better understanding and treatment of disease
- International and dynamic team comprising over 20 different nationalities
- EGYM Wellpass membership
- Permanent employment contract providing stability and long-term career growth opportunities
- Enjoyable work atmosphere with an open-door and open communication mentality
contact information
Sandra Schrli
Senior Talent Acquisition Manager
mail:
Please note that for data privacy reasons well not review applications or CVs sent via email. Unsolicited applications can be submittedhere.
About us
NVision is a quantum biotech startup based in Ulm Germany with Tier 1 investors from the USA and Europe. We are just leaving stealth mode moving from local R&D to global commercialization and expansion.
We are developing a technology that will enable MRI-based imaging of real-time metabolism in the body with tremendous potential for research and applications in oncology cardiology neurology and more. Our company brings together expertise in physics chemistry engineering and medicine and we are collaborating with scientists and clinicians from top medical and research centers such as Memorial Sloan Kettering in New York MD Anderson in Texas Technical University of Munich Cambridge University in the UK and more.
NVision is developing fast robust and easy-to-use hyperpolarization technology for preclinical and clinical research in our POLARIS product line. Those devices are placed close to an MRI scanner in a research or clinical environment to produce hyperpolarized contrast agents on demand in a fast fully-automated multi-step chemical process. Key steps of the process contain fluidic transport across multiple vessels and chemical mixing and separation processes in fully-reuseable or single-use disposable fluid paths. We develop our commercial products jointly with external design and manufacturing partners and the process development as well as the design and manufacturing of prototypes is done entirely in-house.
We offer a dynamic international working environment with immense room for growth that encourages personal initiative and open communication.
Employment Type
Full-Time
