Senior Quality Assurance Engineer in Sunnyvale, California at Cepheid

Date Posted: 6/6/2019

Job Snapshot

Job Description

Job ID: CEP003170

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

Sr. Quality Assurance Engineer –

Cepheid  develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. Cepheid is an operating company of Danaher Corporation. Cepheid offers a broad array of comprehensive, competitive benefit programs that add value to associates´ and their families´ lives. Whether it´s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you´ll like what you see.

Danaher is a diversified technology leader that designs, manufactures, and markets innovative products and services to professional, medical, industrial, and commercial customers. Our portfolio of premier brands is among the most highly recognized in each of the markets we serve. Danaher's portfolio is comprised of five reporting segments: Test & Measurement; Environmental; Life Sciences & Diagnostics; Dental; and Industrial Technologies. Driven by a foundation provided by the Danaher Business System, Danaher's 48,000 associates serve customers in more than 125 countries and generated $13.2 billion of revenue in 2010.

KEY RESPONSIBILITIES


•         Independently plan, coordinate, and report on product quality programs, which provide a basis for sound technical decisions using techniques in experiment design and data analysis.

•         Provide input to budget process and project schedules.

•         Represent QA on development, current business or product improvement projects. Assure accuracy of product labeling and compliance.

•         Generate, prepare and issue complex data for assigned quality reports.

•         Provide input in Customer Feedback failure investigations.

•         Review, implement, or revise product, project, and program quality activities.

•         Provide design review and risk assessment expertise.

•         Approve the design, implementation, and schedule for QA projects.

•         Recommend appropriate field actions to product regulatory committees.

•         Accept/reject advertising, technical product, and support literature. Identify and/or perform vendor audit or site visits.

•         Initiate, recommend, and provide training for QA personnel.

•         Resolve issues of experimental design and data discrepancy in both intra and interdepartmental experiments.


Job Requirements



Qualifications

REQUIREMENTS


BS degree in engineering, technology, or science from an accredited college or university with 5+ years relevant experience OR Master's degree in field with 3+ years experience OR Doctoral degree in field with 0 - 2 years experience.


•              Proven track record with system and or reagent product development

•              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

•              Strong background and experience in NPI 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.

FDA, ISO or cGMP and fast paced manufacturing area preferred.

• Strong analytical skills

• Effective leadership and interpersonal skills

• Good written and verbal communication skills

* PREFERRED QUALIFICATIONS:


• Certified Quality Engineer or Reliability Engineer

• Experience in biomedical research instrument or medical device manufacturing

• Lead Auditor certification

* Hands-on experience in statistical analysis



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 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.