Job Summary The Director, Quality Assurance will manage quality projects, lead Continuous Improvement initiatives, and will drive change to further integrate and implement Ivenix Infusion System into the Fresenius Kabi organization and systems. A key aspect will be to ensure compliance with the U.S. regulatory requirements and FDA expectations are met. This will be in close cooperation with the site quality heads and business partners such as Operations, R&D, Regulatory Affairs and Legal. The Director will manage multiple complex situations where precedents have not been established. Ambiguity and uncertainty will often be the framework of decisions making. A good understanding of the U.S. FDA Medical Device regulations, ability of technical understanding (electromechanical and software), being familiar with manufacturing processes, experience with design and development, good understanding of risk management, and having knowledge of infusion pump functionality and application, will be required to be successful in this position. *This position can be based at either our Warrendale, PA site or our North Andover, MA site, with frequent travel between the two sites. Responsibilities Manage quality projects, lead Continuous Improvement initiatives and, drive change to further integrate and implement Ivenix Infusion System into the Fresenius Kabi organization and systems. Provide quality leadership to product (design & sustaining) improvements. Support in any FDA remediation activities such as leading follow-up in case of FDA observations (483/Warning Letter), untitled letters, and other FDA questions. Stay updated of Field Corrective Actions, FAR/MDR-reporting and 483s of competitors. Prepare plants for and support during and if needed after FDA GMP or MDSAP-inspections. Participate in meetings with FDA and liaise with external service providers. Work closely with SMEs of the competence centers and closely collaborate with MedTech stakeholders. Participate in Expert Circles (ECs) and Corporate Emergency Committees (CECs) to provide input of U.S. regulations and FDA expectations regarding Field Corrective Action (FCA) decisions. Align with R&D on the direction for product risk management activities. Participate in the INS Change Control Board (CCB) and Product Review Process (PRM) to provide additional leadership and critical thinking in refining the post-market surveillance process and tying it into QMS procedures/integrate into global QMS. Job Requirements Bachelor’s Degree required, Master’s preferred; in engineering 10 years of previous experience 5 years of experience in managing individuals. 5 years of experience with infusion pumps. Familiarity with electromechanical and software related medical devices. Experience with leading FDA remediation effort and understanding US FDA expectations. Demonstrated successful experience to drive change and lead projects. Strong written and oral communications. Willingness to travel. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status. Fresenius Kabi (www.CaringForLife.us) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 40,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany. Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr Fresenius Kabi is aware that scammers may attempt to impersonate our recruiters. While we have limited ability to stop these illegitimate efforts, there are some things you can do to protect yourself and not waste time communicating with an imposter. Check the email address – messages from our recruiters will always come from a company account with the Fresenius-kabi.com domain. We have seen imposters send emails using “Fresenius-kaabi.com” which of course includes an extra “a” in “Kabi.” Check our website to see if the position you were contacted about is actually posted. Be wary if someone asks you for personal information. We do not need your driver’s license, social security number, or bank account information before we have made you a conditional offer of employment. Refuse to pay any upfront fees. Fresenius Kabi never charges you a fee to apply for a job at Fresenius Kabi. We will not send you an invoice for equipment (such as a laptop) that we promise to order and reimburse you for once you start working. If you have any questions at any stage of the process, contact us at Careers@fresenius-kabi.com. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.