Job Description
Our company is seeking a qualified professional to play a key role in the development of complex medical devices. The ideal candidate will have a strong interest in the field and experience working with electronic, software, and mechanic systems.
Duties and Responsibilities
* Define and ensure compliance with quality requirements for drug delivery systems and medical devices in development projects.
* Evaluate and verify product design and manufacturing processes to ensure conformity throughout the entire product life cycle.
* Collaborate with cross-functional teams to analyze risks and develop mitigation strategies.
* Create and approve documents for design verification and validation.
* Develop and release test plans, test setups, and design of experiments.
* Review and approve changes to product design and manufacturing processes.
* Serve as the primary contact for customers and suppliers regarding product quality, including measures such as NC, CAPA, SCAR, etc.
* Collaborate in the qualification and validation of equipment and processes.
* Provide support during audits by customers or authorities.
Requirements
* Bachelor's degree in a technical or scientific field or equivalent.
* Several years of experience in medical technology products, pharmaceuticals, and/or in-vitro diagnostics.
* Practical experience in risk management methods for medical devices.
* Knowledge of quality and problem-solving techniques.
* Familiarity with regulatory requirements for medical devices (MDR, EN ISO 14971, 21 CFR 820, EN 13485).
* A structured and result-oriented work approach.
* Ability to prioritize tasks, make decisions, and proactively participate in projects.
* Solution-oriented and communicative personality.
* Excellent communication skills across all levels, internally and with customers.
* Willingness to travel up to 10%.
* Proficiency in German (B2) and English (C1).