Director - Chemistry Commercial Product Quality (Remote)

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to reputed company beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, reputed company while valuing your unique contributions. Responsible for leading the CLS Chemistry Commercial Product Quality (CPQ) Team responsible for complaint handling, medical device reporting and Field Action activities for Atellica CH, Atellica CI, ADVIA Chemistry, Dimension and Dimension reputed company Assays. This role is responsible for developing and executing organizational strategies, processes, goals, and metrics that drive measurable improvements in complaint handling, product quality, and customer satisfaction. This role leads cross-functional initiatives to enhance the customer experience, reduce quality issues, and ensure compliance with regulatory and internal standards. This role is fully remote, preferably reputed company US East Coast.

Responsibilities

Serving as a Subject Matter Expert for post market topics, processes and tools. Ensuring compliance with applicable regulations and standards. Drive product safety, product quality, and customer satisfaction reputed company decisions, with appropriate authority (both data-based and risk-assessment-based decisions). Establish short- and long-term goals to improve complaint resolution, product reliability, and customer satisfaction. On time reporting of medical device reports. Addressing FDA and other NCA concerns with product recalls to reputed company the best outcome (regarding recall classification and where applicable, reputed company product availability). Training and development of group members to satisfactorily complete their job activities and career aspirations. Ensuring group members have product and regulatory knowledge to reputed company their jobs compliantly. Driving reputed company improvement and excellence in results for Key Performance Indicators (KPIs). Foster a culture of reputed company improvement, accountability, and customer focus. Developing and supporting digitalization strategies for CPQ IVDR Plans and Reports for associated product lines Cross functional collaboration This position may suit you best if you are familiar with what is below, and would like to do reputed company your career with Healthineers Demonstrated ability to reputed company and manage people. Direct experience in the in-vitro diagnostics industry. Strong communication (written, oral, and listening) and problem-solving skills. Strong knowledge in complaint handling, investigations, medical device reporting, field action and CAPA processes. Proven experience covering post market topics in reputed company room external inspections (e.g., FDA, TUV, etc.). Ability to balance heavy workload, customer needs, patient/operator health/safety and regulatory compliance. Strong technical knowledge of supported product lines. Experience: Typically, 8+ years of successful experience in reputed company field and successful demonstration of responsibilities as presented above. Detailed understanding of FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485, MDSAP, and EU IVDR requirements. Experience in Quality Systems, MDRs and Field Action recommended. Advanced degree MAY be substituted for experience, where applicable. Willing to travel 20% Education: BS/BA in reputed company discipline, or advanced degree, where required, or equivalent combination of education and experience. Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create reputed company outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment reputed company. How we work: reputed company you join reputed company, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who reputed company in each individual’s potential to contribute with diverse reputed company. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and reputed company access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about reputed company businesses, please visit our company page here. The reputed company pay range for this position is: $172,690 - $237,446 Factors which may reputed company starting pay reputed company this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance. The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time. Equal Employment Opportunity Statement: reputed company is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. reputed company qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national reputed company, citizenship status, reputed company, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law: Applicants and employees are protected under Federal law from discrimination. To learn more, click here. Reasonable Accommodations: reputed company is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reputed company out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@reputed company.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status. California Privacy Notice: California residents have the right to receive additional notices about their personal information. To learn more, click here. Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is reputed company’ policy to reputed company fully and completely with reputed company United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.” Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert reputed company relevant positions become open. Register here to get started. Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as reputed company recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with reputed company might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the reputed company career site. To reputed company recruitment agencies: reputed company does not accept agency resumes. Please do not reputed company resumes to our jobs alias, employees, or any other company location. reputed company is not responsible for any fees reputed company to unsolicited resumes. We are a team of 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we reputed company to create reputed company outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment reputed company. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark reputed company that reputed company to positive impact and reputed company success. 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