Quality Systems Specialist III in Sunnyvale, California at Cepheid

Date Posted: 10/8/2019

Job Snapshot

Job Description

Job ID: CEP003616

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

TITLE: Quality Systems Specialist III (Weekend Shift: Sat - Wed)

JOB SUMMARY:


Responsible for general support and maintenance of the Quality System within the requirements of FDA's Quality System Regulation (QSR) and ISO 13485 (ISO). Specifically, functions including record review, product release and document control fall under this position. (Weekend Shift: Sat- Wed))

PRIMARY RESPONSIBILITIES:


• Review records and documents, for completeness and compliance with QSR and ISO requirements.
• Review batch record to support release of raw materials, work in progress and final products. This includes reagents, components and instrumentation-related products.
• Generate standard operating procedures to define and improve quality system functions.
• Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Reports.
• Support the eDMS electronic documentation process as needed.
• Lead and participate in interdepartmental initiatives for continuous improvement.
• Provide companywide training on general quality principles and specific procedural requirements.
• Facilitate process improvement within other department, through the use of training, coaching, and team participation.
• Support the corrective action program, with hands on ownership for investigation and resolution of issues.
• Participate in the internal auditor program.

Job Requirements



Qualifications

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES (MINIMAL COMPETENCIES)


• Bachelor's degree in scientific, quality system, or related discipline, with practical experience in a regulated manufacturing environment or equivalent experience
• A minimum of 4-6 years of relevant experience.
• Excellent verbal and written communication skills in group or one-on-one settings.
• Computer skills, e.g., word, excel, access, Microsoft project, electronic documentation systems, ERP systems.
• Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics.
• Understanding of general mathematical principles and calculations, at college entry level.
• Ability to perform routine statistical applications.
• Understanding of SPC techniques.
• Experience in compiling data to support metrics analyzing current process.
• Understanding the Design of Experiments, root cause analysis, failure analysis, six sigma and general troubleshooting principles, and the ability to transfer those skills to others, either individually or in a group setting.

PREFERRED QUALIFICATIONS:
• Experience in DNA diagnostics or other medical devices
• Certified Quality Engineer, Certified Quality Auditor or similar certification.

PHYSICAL DEMANDS
• Ability to work in an office environment

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.



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, 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.