Head of Global Design Assurance Engineering(m/w/x)

We are not offering you a job, but rather we are offering you a workplace that feels like home at Greiner Bio-One. # Head of Global Design Assurance Engineering (all genders) Location: Kremsmünster, AT, 4550 Frickenhausen, DE, 72636 Travel activity: 30% Job Type: Permanent ## Your Challenge We are looking for a skilled and driven leader to join our global quality team. As the Head of Global Design Assurance Engineering at Greiner Bio-One International GmbH, you will lead and optimize global design control processes from a Quality Management (QM) perspective. Your primary focus will be to harmonize and continuously improve design assurance practices across our Preanalytics (PA) and Bioscience (BS) business units, ensuring compliance and efficiency for both regulated and non-regulated products. Your main responsibilities will include: * Lead and ensure compliance with design control processes across the organization. * Collaborate with product development teams to promote and maintain the quality of product development projects. * Oversee the timely completion of design control deliverables for design changes, clinical, and new product development projects. * Conduct independent reviews of design control projects and changes. * Define quality plans as part of the design control strategy. * Review and approve product and material specifications. * Establish and drive risk management activities in the early stages of product design. ## Your profile * Hold a Bachelor’s degree in a relevant life science or engineering discipline. * Bring over 10 years of experience in international quality engineering, with a strong focus on FDA regulations. * Have more than a decade of expertise in the medical device sector. * Possess a deep understanding of leading QM processes and tools. * Demonstrate proven leadership abilities in managing strategic quality initiatives. * Showcase autonomy and a proactive approach to your work. * Previous exposure to global companies and diverse cultures is advantageous. * Be proficient in English; additional languages are considered a plus. * Office location: any GBO site. ## Our Offer * We offer you a role in a global QM environment with the opportunity to further develop your existing qualifications. In addition to our many attractive social benefits, the minimum annual salary in Austria is based on employment group IV of the collective agreement for the chemical industry. In other countries, compensation may vary based on local market conditions and legal frameworks. We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants – regardless of characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply. Job ID: 2751