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Complaint Analyst II, Post Market Quality

Company: Cepheid
Location: Sunnyvale
Posted on: April 3, 2024

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 Complaint Analyst II, Post Market Quality is responsible for maintaining customer-facing and field activities including complaint handling and product investigations activities, coordinating Quality System / Regulatory Compliance (QS/RC) interactions, requirements and compliance activities interfacing with Technical Service, Technical Support and other customer support teams, and executing Quality Systems and Regulatory Compliance requirements in conjunction with Company, Business and Regulatory requirements. You will have growth opportunities within Post Market Quality, and other Quality related functions.

This position is part of the Post Market Quality team and will be Hybrid at Sunnyvale, CA. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

  • Support integration of the Post Market Process into all facets of the QMS to include management controls, Complaint Handling, Corrective and Preventive Actions, and Risk Management.
  • Support assessing Customer Complaints in a timely manner, ensuring compliance to 21CFR820, ISO 13485, and other quality systems regulations and regulatory standards, as applicable.
  • Support changes to QS/RC processes through timely analysis and completion of field reports, service requests, and customer complaints.
  • Continuously review requirements and practices in customer-facing responsibilities to ensure compliance to business, customer, and regulatory needs.
  • Provide QS/RC input and partner with Quality Systems to continuously evaluate and improve internal compliance and customer facing systems.

    The essential requirements of the job include:
    • Bachelor's degree or equivalent with 2+ years of related work experience OR Master's degree in field with 0-2 years of related work experience.
    • Functional knowledge of Quality, Regulatory Compliance, and operations systems and processes to include GMP and QSR requirements for medical devices. (ISO 13485, FDA's QSRs, EU's MDD, Canadian Regulations) is required.
    • Possess essential skills for self-directed manner, prioritizing workload and responsibilities.
    • Strong written communication, interpersonal, negotiations and problem-solving skills.
    • Exceptionally strong team player with excellent interpersonal, and experience working with end-users in a mentoring capacity.

      It would be a plus if you also possess previous experience in:
      • Post Market Surveillance requirements
      • Using Salesforce.com

        Cepheid, a Danaher operating 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.

        At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.

        The salary range OR the hourly range for this role is $81,100-$110,100. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.

        This job is also eligible for bonus/incentive pay.

        We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

        Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

        At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

        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 applyassistance@danaher.com to request accommodation.

Keywords: Cepheid, Sunnyvale , Complaint Analyst II, Post Market Quality, Professions , Sunnyvale, California

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