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Senior Reagents Quality Specialist/Engineer, New Product Introduction in Sunnyvale, California at Cepheid

Date Posted: 5/10/2019

Job Snapshot

Job Description

Job ID: CEP003572

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

    • Job Description Summary
    • This position supports quality systems activities related to assay development, especially design control and risk management activities in accordance with FDA and ISO regulations. The ideal candidate will have a Quality Systems/Quality Engineering background in molecular biology products or molecular diagnostic products utilizing nucleic acid amplification tests (e.g. PCR).
    • Job Description

      Duties and Responsibilities:

      1. Participate as Quality representative on select product development teams which includes providing guidance for Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Risk Assessments, and Design Reviews; and provide guidance and decisions on product development activities to ensure continued compliance with internal procedures and applicable ISO and FDA standards.

      2. Provide guidance to stability testing, test methods, sample plan definition, and validation development.

      3. Fulfill all quality planning, stability, and risk management deliverables with feedback from cross-functional teams. Represent the extended Quality Systems team to the product development teams.

      4. Ensure required documentation is completed prior to new product launch.

      5. Provide Technical Quality support for post market investigations and design changes, including documentation of investigations following standard out of specification SOPs and assessment of changes using design control methods.

      6. Work with management for continuous improvement of the Quality Systems, including the design control, risk management, document generation, and design testing processes.


Job Requirements



Qualifications

Knowledge and Skills:


1. B.S. in Chemistry, Biology, or related physical or biological science field.

2. Minimum of 5 years work experience in Quality with a focus on assay development in a medical devices or pharmaceutical industry with applicable knowledge of cGMP, ISO, and FDA regulations.

3. Experience in implementing design control and risk management activities. Strong knowledge of process validation in reagent assay products.

4. Knowledge of design of experiments. Excellent problem solving and analytical skills. Comfortable with technical data and capable of making risk-based recommendations taking into account broad perspectives that support both the regulations and the business.

5. Effective interpersonal and communication skills, and capable of representing Quality Systems to, and forming strong working relationships with, functions such as Research & Development, Engineering, Technical Operations, Regulatory Affairs, and Project Management.

6. Capable of multitasking and prioritizing several projects independently (project management-like skills).



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.