Job Responsibilities
* Serve as the Quality SPOC for allocated Medical Device / Combination Product development projects, ensuring compliance with design control and risk management procedures.
* Collaborate with QA representatives from other functions to ensure quality robustness of the interface between the Drug Product and the Device Component forming the Combination Product.
* Create and implement Risk Management Plans and Reports, facilitate FMEAs, define Delivery System specifications including Drug Product / Component interface, and ensure completion of all necessary GMP release documentation.
* Drive quality resolution for investigations related to the delivery system and assess change controls.
* Represent the department at Quality Review Board and Change Review Board meetings.
Qualifications
* BSc in Life Sciences, Chemical or Mechanical Engineering; Graduate degree preferred.
* Experience in device quality or device development.
* Proficiency in risk management concepts, tools, and Design Control deployment.
* Understanding of the biotechnology industry, especially combination products, and experience in a global environment preferred.
* Knowledge of cGMPs and international regulatory requirements (QSR, MDR, ISO13485, etc.).
* Strong teamwork, collaboration, and communication skills.
* Problem-solving and decision-making skills; hands-on experience with Six Sigma / DMAIC preferred.
* Fluent in English; German language skills advantageous.
Additional Information
* Unlimited employment contract with Hays (no freelancing).
* Work for a renowned company in an innovative, international environment.
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