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Senior Quality Assurance Engineer in Sunnyvale, California at Cepheid

Date Posted: 3/16/2019

Job Snapshot

Job Description

Job ID: CEP002458

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

The successful candidate will support Quality Systems activities related to new product development, manufacturing sustainment, especially design control and risk management activities, in accordance with FDA and ISO regulations. The ideal candidate will have a Quality Assurance Engineering background in molecular diagnostic products utilizing nucleic acid amplification tests.

Essential Job Responsibilities:

  • Applies advanced technical experience, skill and performance to support new product introduction core teams to successfully develop in  diagnostic devices.
  • Maintains continuous alignment of program scope with strategic business and Quality objectives and possesses advanced skills in leadership, communication, influence, cross-cultural awareness, negotiation and conflict resolution.
  • Works cross-functionally and consults frequently with Manufacturing, Engineering, Research and Development, Quality, Regulatory and Marketing, in addition to other functional groups.
  • Routinely communicates project goals, status, requirements, and deliverables to Quality Management

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 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.