Quality System Analyst in Sunnyvale, California at Cepheid

Date Posted: 5/11/2018

Job Snapshot

Job Description

Job ID: CEP001358

About Us

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).


Description

Job Summary – Quality System Analyst:



Cepheid is seeking a Quality System Business Analyst (BA) responsible for coordinating and planning development timelines along with the IT technical/developer teams to build an electronic Quality Management System (eQMS) at Cepheid. The BA is responsible for facilitating and gathering all requirements documentation which will be needed to develop an eQMS system for Cepheid Quality System (including CAPA, Non-Conformances and Qualifications Management that will be deployed in the initial phase). The Quality System Business Analyst serves as the Quality Representative in cross-functional core teams with responsibility for the project from a Quality and Compliance perspective.  This position will be filled in Sunnyvale, CA.



Essential Job Responsibilities:




  • Be the Subject Matter Expert for assigned eQMS process areas and drive towards Process Excellence for integrating these Quality System Elements with Pilgrim

  • Understand the comprehensive cross-functional business case, relationships, and interdependencies across process areas, globally.

  • Be the Project Manager and lead project teams for assigned projects; Support colleagues in their projects, as required.

  • Analyze, design, develop, deliver, and maintain eQMS processes and models that deliver value to the business.

  • Author, release and own Quality System and/or Wiki documentation, as appropriate, for assigned eQMS process areas.

  • Define detailed process specification, facilitate/execute UAT testing, and provide communication on implementation.

  • Ensure compliance to all appropriate Quality System and Regulatory requirements.

  • Provide consultation and process content expertise to end-users, assist with troubleshooting issues, and recommend solutions.

  • Maintains continuous alignment of program scope with strategic business and Quality objectives and possesses advanced skills in leadership, communication, influence, cross-cultural awareness, negotiation and conflict resolution.

  • Routinely communicates project goals, status, requirements, and deliverables to Quality Management


    Key Accountabilities



  • Manage the program through Core Team members and their Extended Teams to deliver robust eQMS tool/process which meet the defined delivery timeline, design inputs and quality metrics to meet business unit goals.

  • Creates the Quality Plan and Reports

  • Communication focal point to the external vendor as well as internal stakeholders including senior leaders.

  • Identify and drive countermeasures in instances when project is overdue or exceeding budget

  • Establish and monitor use of tools for project tracking and management

  • Establishes project milestones and monitors adherence to master plan 

  • Applies project management processes to achieve the highest performance and value added effort

  • Works effectively with all team members, stakeholders and supervisor

  • Coaches and develops extended Quality team members as necessary to assure common understanding of the eQMS process and project goals

  • Facilitate the design, implementation, testing, and adoption of all future Pilgrim modules (TBD) or other system Cepheid may decide to purchase.

  • Manage the integration with other Quality systems (such as Compliance Wire, Agile, SAP, SalesForce, etc…); understand the impact that changes can have across multiple integrated IT systems.

  • Effectively communicates and maintain visual tools for project tracking and management

  • Effectively employs Danaher Business System (DBS) tools and concepts to maximize efficiency and quality

Job Requirements



Qualifications

Minimum Requirements:



  • A Bachelor’s degree with 9+ years of experience or Master’s degree with 7+ years of experience, preferably in areas of life sciences, engineering, or quality assurance.

  • Experience with project management within the medical device industry - Quality Assurance or Information Technology group is preferred

  • Knowledge of FDA regulations and ISO standards is required.


    Knowledge and skills:



  • Demonstrated leadership skills and the ability to influence others without direct authority.

  • Project management Professional (PMP) certification or similar certification such as KepnerTregor PM training is strongly recommended.

  • Experience representing their department during quality system audits.

  • Demonstrated superior communication skills, both oral and written.

  • Fast learner, and able to quickly become adept at using the Danaher Business System tool set

  • Readily accepts responsibility and accountability for project success and key decisions

    Preferred Requirements:



  • Experience in the medical device industry, knowledge of CFR 21 Part 820 (QSR), ISO 13485

  • A quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations. Examples include the CQE, CRE, etc.


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.


At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.