SunnyvaleRecruiter Since 2001
the smart solution for Sunnyvale jobs

Sr. Quality Systems Specialist

Company: Cepheid
Location: Sunnyvale
Posted on: November 22, 2021

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.

Cepheid is seeking a Senior Quality Systems Specialist responsible for evaluating and improving the QMS by employing standard methodologies to ensure compliance to applicable Medical Device and IVD regulations/standards and Danaher Polices. The Senior Systems Specialist will also participate in the CAPA program by not only owning CAPA investigations but also by working closely with CAPA partners and provide mentorship on CAPA documentation.
In this role, you will have the opportunity to: Own CAPAs and perform detailed investigations and implement robust corrective actions

Working with CAPA owners to plan and document investigations, action implementation and efficiency verification on time and according to procedure.

Provide continuous and meticulous assessment of the Quality Management System including CAPA, Internal Audit, and other processes as vital to identify and implement improvements.

Be a subject matter authority on CAPA practices.

Participate in MDSAP preparation, assessment, and audit management activities.

Participates in external audits (e.g. FDA, ISO, Danaher Corporate).

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 ensuring 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 Food & Drug Administration (FDA) and European Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory requirements.

The essential requirements of the job include: 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.

Excellent verbal and written communication skills.

Detailed CAPA process knowledge to be able to guide/train those new to CAPA

Possesses significant knowledge of domestic and international quality systems and other standards such as FDA QSR, IVDR, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and 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 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 .

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll 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 we'll empower you to push the boundaries of what's possible.

If you've ever wondered what's within you, there's no better time to find out.

#LI-LH2

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll 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 COVID-19 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 you've ever wondered what's within you, there's no better time to find out.

Keywords: Cepheid, Sunnyvale , Sr. Quality Systems Specialist, Other , Sunnyvale, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Sunnyvale RSS job feeds