Senior (5-10 years)

Responsibilities·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Head of the injection molding department for medical technology (clean room production), including production planning and control as well as team leadership·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Development, optimization, and monitoring of injection molding processes (2 components) to produce medical devices made from thermoplastics in clean room conditions·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Responsibility for the implementation of new tools and materials into serial production·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Process validations in accordance with ISO 13485 and support in the preparation of qualification and validation documentation (IQ, OQ, PQ)·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Analysis and resolution of process deviations in close collaboration with Quality Assurance and Production·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Support during audits (internal/external) and ensuring compliance with regulatory requirements·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Execution of test series, including evaluation and documentation of results·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Contribution to continuous improvement initiatives (CIP, Lean)·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Training of production staff regarding new processes or process changes&nbsp; Profile:·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Degree in Plastics Engineering, Mechanical Engineering, Medical Technology, or a comparable qualification·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Several years of professional experience in thermoplastic injection molding, ideally in the medical technology sector·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; At least 5 years of management experience with employees in a complex production environment·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Experience in production planning and control in injection molding·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Experience in two-component (2K) injection molding is desirable·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Solid knowledge of the DIN EN ISO 13485 standard and experience with processes requiring validation·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Practical experience in cleanroom production environments·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Expertise in process analysis and optimization·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Proficiency in working with CAQ and ERP systems is an advantage·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Strong quality awareness, structured working style, and team-oriented mindset·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Willingness to travel (occasionally, within Central Europe)·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Good command of Romanian and English, both written and spoken

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