Quick Job Search
Keywords:
Company Name:
Job Type:
Location:
Job Seeker Tools
Latest Jobs
Job Seeker Tools
Your Saved Jobs
Build Your Professional Profile
Similar Jobs
Capgemini
Applications Consultant 2 - Netsuite Technical in San Francisco, CA
PetSmart
Merchandising and Inventory Manager in San Leandro, CA
Capgemini
Senior Applications Consultant - SAP OTC in San Francisco, CA
WALGREENS
Customer Service Associate in Marysville, CA
Deloitte
HRST Lead, Program Advisory and Delivery in Costa Mesa, CA
Veterans Health Administration
Registered Nurse Special Procedures in San Diego, CA
Coupa Software
Senior Director, HR Business Partner, Engineering and Product Management in SanMateo, CA
Featured Employers
Quality Systems Specialist
Company: Cepheid
Location: Lodi, CA
Employment Type: Full Time
Date Posted: 10/25/2021
Expire Date: 11/24/2021
Job Categories: Accounting/Auditing, Healthcare, Practitioner and Technician, Information Technology, Quality Control, Research & Development, Medical, Environmental
Job Description
Quality Systems Specialist

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 worlds 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, were working at the pace of change on diagnostic tools that address the worlds 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 Quality Systems Specialist II is responsible for maintaining the Quality System shared services including CAPA, Internal and External Audit and Document Control at Cepheid. This position is accountable for initiating and supporting quality systems activities in all aspects of the business, including identification and implementation of continuous process improvement activities.

This position is part of the Quality Organization and will be located in Lodi, California.

In this role, you will have the opportunity to:

  • Be responsible for the Change Control release of all Change Orders for the organization. Establishing systemic process for review Change Orders in accordance with industry standard GMP practices. Supervise direct reports responsible for Change Order review and processing. Provide guidance on GMP and educate associates on best practices
  • Work as a team member to ensure all Quality System Shared Service functions are reviewed and that changes are properly documented and structured
  • Ensure proactive compliance to all applicable internal, domestic and international quality regulations US 21 CFR 820 (QSR), ISO 13485, etc.
  • Maintain policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) as well as all other applicable global regulatory requirements
  • Collaborate across the organization at all levels, across functional groups and geographic locations
  • Utilize Danaher Business System (DBS) tools to drive compliance and effective processes
  • Assure that there are no significant interruptions to the business due to quality or compliance issues

The essential requirements of the job include:

  • High School degree (or equivalent experience) with 4-6 years of related work experience OR AA or Technical Trade Degree with 2-4 years of related work experience.
  • Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals
  • Able to work effectively in a collaborative team environment, across multiple functions. Able to skillfully manage conflict and bring issues to timely resolution
  • Able to apply business understanding and technical expertise and full knowledge of other related disciplines to assist in solving complex technical and business issues
  • Able to make judgment calls using combination of knowledge of regulations, knowledge of technology, critical thinking, and interpretation of intent of the regulations

It would be a plus if you also possess previous experience in:

  • Experience and understanding of Quality System and Regulatory Compliance processes within the medical device industry
  • Knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulations

Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its 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, youll also be joining Danahers global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, youll 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 well empower you to push the boundaries of whats possible.

If youve ever wondered whats within you, theres no better time to find out.

When you join us, youll also be joining Danahers global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, youll 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 require all US and Puerto Rico employees to be vaccinated against COVID19 as a condition of employment, subject to reasonable accommodation as required by law.


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.

If youve ever wondered whats within you, theres no better time to find out.

Contact Information
Contact Name:
Company Name: Cepheid
Phone Number:
Contact Email:
Website: https://jobs.danaher.com/global/en/...
Company Description:

Please visit our employer showcase!
Apply Now | Forward Job to a Friend | More Jobs From This Employer