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InWork360

Quality Operations Engineer - First Shift (2640018932)

Other

Unknown

Yearly

No

Newark, Ontario, Canada

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 [Register to View] which makes everything possible.

*First Shift is 8:00am to 5:00pm. With following weekly schedule: Sunday, Monday, Tuesday, Wednesday, and Thursday.*
The *Quality Operations Engineer* role is heavily collaborating in the non-conformance process in Sustaining Operations and supports manufacturing and complaint handling/field sustaining leading to improved compliance with corporate policies, 21CFR820, ISO 13485, the Medical Device Directive, and other applicable regulatory agencies, while striving for continuous improvement.
This position is part of our Quality Engineering Team located in Newark, CA.
*In this role, you will have the opportunity to:*

* Generate, prepare and issue complex data for assigned quality reports

* Provide support to the nonconformance process investigations and dispositions providing technical guidance, drive improvement activities to reduce non conformances and reduce turnaround time of the process

* Serve as a subject matter expert on the NC process to drive containment activities on time

* Provide input in Customer Feedback failure investigations, approve the design, implementation, and schedule for QA projects

* Establish and monitor use of risk assessment tools; communicate and maintain visual tools for project tracking and management

* Effectively employ Danaher Business System (DBS) tools and/or Lean manufacturing concepts to maximize efficiency and quality

* Typically serves as a project or team leader for a complex business concept or application

* Experience representing their department during quality system audits


*The essential requirements of the job include:*

* Bachelor’s degree in field with 2+ years of related work experience OR Master’s degree in field with 0 - 2 years of related work experience

* Strong background and experience in Quality Systems processes as NC, CAPA Quality for instrumentation hardware and qualification

* Experience in the application of production and process controls including process validation, process control plans and statistical process control

* Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations

* Experience with risk management and design control principles

* Experience representing their department during quality system audits


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

* 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, CQA, etc.

* Certified in Lean manufacturing and/or Six Sigma

* Experience in product mechanical evaluation & testing and GD&T

* Hands-on experience in advance statistical analysis

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 [Register to View] />
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.
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 [Register to View] 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 [Register to View] />
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 [Register to View] [Register to View] to request accommodation.

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