Quality ManagerFull-timeLegalEntity: Arvato USA LLCCompany DescriptionArvato is an innovative and leading global 3PL service provider in supply chain management and e-commerce. With 20,000 team members at over 100 locations, we focus on the Consumer Products, Tech, Healthcare, Automotive and Publisher industries.You will work in an environment built on collaboration, respect, commitment and curiosity, where you can grow, contribute your ideas, and make an impact. Be part of the team that delivers logistics excellence and shapes supply chains globally. Working at Arvato means: Together, we’re on it.Job DescriptionThe position of the QA Manager Healthcare includes all activities related to Quality Assurance ofpharmaceutical products and medical devices to ensure a proper implementation of the qualitypolicy, the quality assurance system, the compliance with GMP/GDP rules and all GxPrequirements in accordance with e.g. EN ISO 9001, EN ISO 13845 and other country specificrequirements. This role is also responsible for ensuring that all requirements for Quality Assurance areunderstood 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 controlSupporting 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 preferredWE OFFERMedical, 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 activitiesAdditional InformationAll your information will be kept confidential according to EEO guidelines.Disclosure requirements pertaining to the collection of your personal data:Responsible for processing the information provided in your application is the company specified in the job advertisement, with its registered office as indicated. The company processes your data for the purpose of establishing an employment relationship on the basis of Art. 6 (1) b GDPR / Section 26 (1) sentence 1 BDSG.The retention period for your data is determined by the statutory time limits applicable in the respective country, beginning upon completion of the recruitment process. You can find thesehere.You can contact the company’s Data Protection Officer at the above-mentioned postal address.Further information on data protection and your rights can be foundhere.We strive to be an equitable and inclusive workplace for our employees and value their diverse perspectives, which contribute to the diversity of our company. Therefore, we welcome applications from people who enrich our company with their identity, background and personal experience. We want to keep the application process as simple as possible for you: focus on a meaningful resume; we do not require an elaborate cover letter. Please know that we can only accept your application through our online application portal.Learn more about our commitment to Equal Opportunity and Accommodation Information here.Recruiting-Platform powered by SmartRecruiters.By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy applyJob LocationGoogle Maps requires functional cookies to be enabledI'm interestedI'm interestedPrivacy NoticeImprint
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