Senior Quality Systems Specialist in Sunnyvale, California at Cepheid

Date Posted: 11/16/2018

Job Snapshot

Job Description

Job ID: CEP001852

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

Cepheid is seeking a Senior Quality Systems Specialist responsible for evaluating and improving the Quality Management System by employing best practices to ensure compliance to applicable Medical Device and IVD regulations/standards and Danaher Polices. The Senior Quality Systems Specialist will participate in the Cepheid QMS internal audit program to verify compliance to internal Cepheid Quality Policies and Standard Operating Procedures, and external regulatory and customer requirements. The Senior Quality Systems Specialist will support FDA, ISO, Danaher corporate, and other external audits. The Senior Systems Specialist will also participate in the CAPA program by working closely with CAPA owners and provide guidance on CAPA documentation.

Essential Job Responsibilities:

  • Functions as Lead Auditor to schedule, plan, perform, and document internal audits of Cepheid’s QMS.
  • Ensures that all internal audit findings are closed in a timely manner with effective corrective action by assisting observation owners on investigations, action plans, and/or verification plans.
  • Participate in MDSAP preparation, assessment, and audit management activities.
  • Participates in external audits (e.g. FDA, ISO, Danaher Corporate).
  • Working with CAPA owners to plan and document investigations, action implementation and effectiveness verification on time and according to procedure.
  • Provide continuous and rigorous assessment of the Quality Management System including CAPA, Internal Audit, and other processes as necessary to identify and implement improvements.
  • Be a subject matter expert on Internal Audit and CAPA practices.
  • Build working relationships with cross functional teams including Development, Supply Chain, Program Management, Commercial Operations, Regulatory Affairs, etc. to ensure process solutions are compliant, efficient and adaptable to business units, sites and functions throughout the world.
  • Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management.
  • Implement tactical plans to meet Company and Corporate objectives, and supporting the development and implementation of policies to ensure compliance with applicable US Federal and local regulations
  • Maintains up-to-date knowledge and ensures compliance with local, state, and federal regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Regulation (MDR) as well as other applicable global regulatory requirements.

Job Requirements



Qualifications

Qualifications:           

EDUCATION:

  • Bachelor’s degree in field with 5 years of related experience or Master’s degree in field with 3 years of related experience or Doctoral degree in field with 0-2 years of related work experience.

EXPERIENCE DESIRED:

  • Excellent verbal and written communication skills.
  • Lead Auditor Certification or CQA(B)
  • Possesses significant knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations.


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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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.