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Danaher Corporation Quality Compliance Analyst, Customer Care Americas in Sunnyvale, California

COMPANY OVERVIEW:

At Cepheid, we are passionate about improving health care through faster, more accurate diagnostic tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us, every moment of every day, as we develop rapid groundbreaking solutions to solve the world’s most complex health challenges.

Our associates are involved in every stage of molecular diagnostics – from ideation and innovation through development and delivery of life-changing advancements in healthcare-associated infections, sexual health, critical infectious disease, virology and oncology applications. For more details, visit us at www.cepheid.com or follow us on Twitter. (@CepheidNews)

As part of the Danaher family of companies, our work at Cepheid is supported by a global science and technology innovator. In addition to Danaher’s unrivaled leadership training and professional development programs, this relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life’s Potential.

POSITION SUMMARY:

The Quality Compliance Analyst ensures our Americas Customer Care organization complies with internal quality and government and industry compliance standards. Valued candidates will have a working knowledge of FDA/ISO regulations, experience with cGMP settings and an eagerness to learn in a rapidly-growing company.

ESSENTIAL JOB RESPONSIBILITIES:

  • Analyze case, workorder and other transactional records to identify non-conformances, study trends, develop reports and help drive systemic resolutions

  • Perform regular internal quality audits within the Customer Care organization, including Technical Support, Field Service and Repair Center, providing associate feedback

  • Maintain compliance case records, support regular presentations to cross-functional management and collaborate with other functions for timely and effective resolution of quality and compliance issues

  • Compile and synthesize data from interactions between our service associates and internal and external customers

  • Partner with peers when coordinating process analysis, testing and problem-solving across business operations functions

  • Support the maintenance and implementation of our Quality Management System documents (SOPs, work instructions, etc.) for the area of responsibility

  • Routinely seek internal customer feedback and work with Quality Compliance and Process Engineer to incorporate the data into strategies and action plans

  • Develop test plans for our products and services to ensure quality compliance

  • Interface with Global Customer Care and Enablement team to help ensure alignment with quality and regulatory compliance matters

  • Assist our Quality Compliance and Process Engineer in designing solutions to quality management issues, planning, coordinating and reporting on quality programs for the Americas Customer Care team

  • Provide feedback to Training Program Manager on major/minor compliance issues, work closely with training team to ensure associates receive proper instructions to perform their tasks with full compliance to applicable ISO and FDA regulations

  • Support regulatory audits for area of responsibility

  • Demonstrate understanding in areas of process analysis, testing, dashboard requirement gathering, and business processes

  • Assist in gathering data for KPIs and dashboards to track the ongoing performance of current and future customers

  • Support Planned Deviation Request process

TRAINING RESPONSIBILITIES: (REQUIRED)

  • Complete all assigned and required training satisfactorily and on time

MINIMUM REQUIREMENTS:

Education and Experience (in years):

  • High school diploma/GED with 7+ years of related work experience OR

  • Bachelor’s degree in Quality Assurance, Engineering, Biology or Computer Science or related business process with 3 + years of related work experience OR

  • Master’s degree in field with 1+ years of experience

Knowledge and skills:

  • Continuous improvement based on data-driven decisions

  • Basic MS Word, PowerPoint, Excel modelling and data analysis

  • Experience analyzing business processes and quality systems in a mature industry that has stringent quality regulations

  • Strong critical thinking & problem-solving skills with a track record for finding solutions to difficult problems

  • Strong sense of ownership, accountability and high attention to detail

  • Must be self-motivated, demonstrate a “can-do” attitude and be a “results” driven individual with a positive attitude for a timely delivery of agreed upon solutions

PREFERRED REQUIREMENTS:

  • Working experience in a Medical industry/FDA-regulated environment is a plus

  • Experience with Quality Management Systems

  • Experience auditing systems/processes

  • Working technical knowledge of Cepheid products or similar medical devices

Other:

May require minimal international travel for effective execution of projects

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

Operating Company: Cepheid

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