Quality Manager

The position of the QA Manager Healthcare includes all activities related to Quality Assurance of

pharmaceutical products and medical devices to ensure a proper implementation of the quality

policy, the quality assurance system, the compliance with GMP/GDP rules and all GxP

requirements in accordance with e.g. EN ISO 9001, EN ISO 13845 and other country specific

requirements. This role is also responsible for ensuring that all requirements for Quality Assurance are

understood and adhered to by the respective departments.YOUR TASKSContinuous improvement and compliance of the local quality management system (ISO 9001, ISO 13485 and other country specific requirements (e.g. GDP, GMP, FDA, etc.)Flexible adaptation of the Quality Management System to all requirements (e.g. requirements of authorities, customer requirements)Oversight of all quality technical related processes, e.g. maintenance, calibration, pest control Supporting the strategic implementation of the Quality policy and Global Quality SystemReporting of quality KPIs and enforcement of the specified quality in cooperation with all departments involved, including Complaints / Deviations / CAPA / Change ManagementResponsible for the execution of training, according to the respective requirements Decision on the further use of products (blocking, release)Guarantee of the written separation of responsibility with the customer and suppliers regarding all activitiesClose collaboration with other departments, e.g. sales and account management, as well as the global quality teamParticipation in project and process alignments, preparation and performance of management reviewsCompletes assigned MasterControl Action Items within required timelines to ensure timely resolution and compliance with quality system expectationsYOUR PROFILEBachelor’s degree in a scientific, technical, or quality-related field; or equivalent work experience5+ years of experience in a quality role in a regulated environment (medical device, pharma, biotech, or logistics)Working knowledge of ISO 9001, ISO 13485, and FDA 21 CFR Part 820 requirementsProficient in document control systems and training program coordinationExcellent attention to detail and organizational skillsStrong verbal and written communication abilitiesProficiency with Microsoft Office.ISO Lead Auditor Certification preferredExperience with MasterControl or similar eQMS platforms preferred WE OFFER Medical, Dental, Vision, Life Insurance, and Disability Pay401(k) with company matching up to 6%Paid Time Off, including paid holidaysFlexible Spending AccountsVoluntary benefits such as legal and financial assistance, pet insurance, and moreEmployee Assistance ProgramOngoing employee development opportunities including tuition reimbursement, scholarships, and trainingCommuter benefitsEmployee engagement activities