Customer Care Quality and Compliance Specialist - Remote

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Posted 9 days ago United States Salary undisclosed
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Job Description

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting.Learn about the Danaher Business System which makes everything possible.The Customer Care Quality and Compliance Specialist is the subject matter expert in the Customer Care Quality Management System (QMS), owning global Standard Operating Procedures (SOP) and Work Instructions (WI). With good technical writing skills, the incumbent will draft procedures and other quality documentation to ensure adherence to Cepheid quality policies while making them simple to understand and be followed by team members all over the world. The position will lead QMS documentation improvement workshops and collaborate with regional experts to achieve the business objectives.In this role, you will have the opportunity to:Execute on strategic plans to ensure compliance with applicable Quality Systems requirements in conjunction with company business objectivesOwn global Standard Operating Procedures (SOP) and Work Instructions (WI), ensuring procedures are up to date and reflect current business practicesBe the Subject Matter Expert in QMS documentation standards; adhering to Cepheid's documentation processesDraft QMS documents for Global Customer Care, and support Regional teams with local documentationAdminister the Document Control systems for in-scope documentationEnsure alignment and consistency between the different hierarchy levels of QMS documentationProvide training on QMS documentationManage requirements, risks, and implications of written documentationLead SOP overhaul workshopsOwn resolution of non-conformances, corrective and preventive actions (CAPA), and audit findings.Support internal and external auditsSupport other functions within Customer Care groups with the writing of QMS documentsCollaborate across the organization at all levels and regional groupsBuild working relationship with other cross functional organizations that affect Customer Care operations, including Quality, Engineering, Supply Chain, Commercial Operations, and others.Participate in Cepheid continuous improvement process in conjunction with all departmentsThe essential requirements of the job include:Bachelor's degree with 5+ years of related work experience, OR Master's degree with 3+ years of related work experience.Experience with Customer Care or Service Quality systems and proceduresExperience in medical device industry preferredExcellent communication skills; is sensitive to non-native English-speaking personnel - uses standard language to communicate effectively across all regions globallyCritical thinking - strong criteria to identify nuisances within written language that presents a gap, is conflicting, or otherwise not consistentExceptionally strong team player with excellent interpersonal and communication skillsExperience of working in a complex matrix and global business environmentKnowledge of CFR Title 21 - Section 820.200 Servicing and Installation regulations a plusKnowledge of ISO13485 - Medical Device Standards a plusTravel5-10%Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we'll empower you to push the boundaries of what's possible.If you've ever wondered what's within you, there's no better time to find out.#LI-JP1#LI-RemoteWhen you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.If you've ever wondered what's within you, there's no better time to find out.